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Retained Surgical Items: Impact and Prevention

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“It manages energy so you spend yours focused on the patient” Reference: Valleylab™ FT10 Energy Platform [Service Manual]. Boulder, CO: Medtronic 2015.

“Next generation electrosurgical precision” Reference: Based on internal test report # R0064443 Rev A, Ex-vivo Monopolar Procedural Flow Evaluation on the Valleylab™ FT10 Energy Platform; November 2014.

“Freedom of movement” Reference: Based on internal test report #2-108-10, Validation of Milwaukee USG1 marketing report surgeon evaluation of 5mm Cordless Laparoscopic Ultrasonic Shears. April 8 – May 6, 2010.

“Precise dissection and reliable seals from one device” Reference: Based on internal test report #RE00041188, Validation marketing claims: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine labs. October 2015 and February 2016.

“Benefits stick. Tissue doesn't. nonstick nano-coating makes LigaSure™ technology better than ever” References: When Comparing the LF4418 to the LF4318, the nonstick coating on the LigaSure Impact™ device jaws reduces sticking by 67%. Based on internal test report #RE00034755, LF4418 design verification report: benchtop testing using porcine abdominal aorta, mesentery, and renal arteries, with average (lbs.) sticking force. Feb. 24, 2016 and March 25, 2016.

When comparing the LF1837 to the LF1637, the nonstick coating on the LigaSure™ blunt tip device jaws reduces sticking by 41%. Based on internal test report #RE00062678, Benchtop tissue sticking comparison of the Ethicon™* G2, Voyant™* 5 mm Fusion, LigaSure™ LF1637, and LigaSure™ LF1837 devices conducted on porcine uterine tissue using the ForceTriad™ energy platform. Instances of tissue sticking to jaws measured over 110 seals per device. October 5, 2016.

1. Based on internal test report #RE00077194, Bag and device reliability memo. 2016.

2. Based on internal test report #RE00007964, ReliaCatch™ specimen retrieval bag summative validation. 2016.

3. Based on internal test report #RE00072916, ReliaCatch™ specimen retrieval bag 10 mm and 12 mm claims matrix benchmark data. Ethicon, Applied, Anchor, and Genicon are considered the major competitors and ReliaCatch™ device was tested appropriately against their specimen retrieval devices. For CATCH10, as compared with Applied Inzii™*, Anchor Tissue Retrieval System™*, Ethicon EndoPouch™*, Genicon GeniStrong™* and predicate Endo Catch™ Gold device. For CATCH12, as compared with Genicon GeniStrong™* 12 mm and Applied Inzii™* 12/15 mm. 2016.

4. Based on internal test report #RE00070348, Specimen retrieval devices: Specification development & justification. As compared to predicate Endo Catch™ Gold device. 2016.

1. Based on internal report #RE00091644, Benchtop testing: Tissue sticking comparison using porcine uterine tissue with the Enseal™* X1 large jaw vessel sealer vs. the LigaSure Impact™ device (LF4418). April 13, 2017.

2. Based on internal test report #RE00091641, Benchtop testing: Comparison of the renal artery burst pressure using porcine kidneys with the Enseal™* X1 large jaw vessel sealer vs. the LigaSure Impact™ device (LF4418) on the ForceTriad™ and Valleylab™ FT10 energy platforms. April 10 to 12, 2017.

3. Based on internal report #RE00055066, Benchtop testing: Tissue sticking comparison of the Ethicon™* G2 Super Jaw, Olympus ThunderBeat™*, LigaSure™ LF4318, and LigaSure™ LF4418 devices using porcine uterine tissue. Aug. 2, 2016.

4. Based on internal report #RE00057355, Lig-40 product claim LF4418: benchtop testing using porcine uterine tissue. July 29, 2016.

5. Based on internal test report #RE00091643, Preclinical acute testing using a porcine model to compare the Enseal™* X1 large jaw vessel sealer vs. the LigaSure Impact™ device (LF4418) on the ForceTriad™ and Valleylab™ FT10 energy platforms. April 14, 2017.

† Tissue sticking to device jaws instances measured over 110 seals per device using the Valleylab™ FT10 energy platform.

‡ Seal time measured over all vessel size categories using the Valleylab™ FT10 energy platform.

§ Eschar build-up assessed using optical imaging analysis after 20, 40, and 60 seal and divide cycles.

Ω Compared to the legacy devices.

†† Activation time measured over a variety of tissue types and multiple activations per device using the Valleylab™ FT10 energy platform.

1. Based on Covidien product verification report: "Autobipolar Evaluation - Valleylab™ FT10"; RE0064455 Feb 2015

2. Bench testing model used to evaluate sealing time, when compared to the ForceTriad™ energy platform. Based on Covidien memo: "LigaSure Data Sources for VLFT10 White Papers." September 2015 RE00025819 Rev A

3. Based on the Valleylab™ FT10 Service Manual: part number 1079477, REV 01/2015

4. Smarter: As compared to the ForceTriad™ energy platform. Based on the Valleylab™ FT10 Service Manual: part number 1079477, REV 01/2015

5. Simpler: As compared to the ForceTriad™ energy platform. Based on Covidien product validation report: "Product Validation of Valleylab™ FT10 Surgeon & Nurse Evaluation in Simulated Use" January - February, 2015; RE00005401

6. Based on Covidien ex-vivo monopolar report: "Verification - report - Ex-vivo Monopolar Procedural Flow Evaluation on the Valleylab™ FT10 Orion." November, 2014; R0064443 Rev A

1. Based on internal test report #RE00003687, Data collected during 17 procedures for product introduction. April–June 2017.

2. Roje Z, Racić G, Dogas Z, Pisac VP, Timms M. Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blinded study. Coll Antropol. 2009;33(1):293–298.

3. Lachanas VA, Prokopakis EP, Bourolias CA, et al. LigaSure™ versus cold knife tonsillectomy. Laryngoscope. 2005;115(9):1591–1594.

4. Based on internal test report #RE00073873 and #RE00079704, Independent surgeon and nurse feedback collected during Medtronic-sponsored labs. January and February 2017.

5. Based on internal test report #RE00077022, Porcine testing. Jan. 9–10, 2017.

6. Based on internal test report #RE00011247, Benchtop testing comparing the BiZact™ tonsillectomy device with the E1551X Valleylab™ Hex-locking blade electrode. March 23, 2017.

7. Based on internal test report RE00015788 collected during Medtronic-sponsored tissue testing conducted on March 23, 2017

8. Wilson YL, Merer DM, Moscatello AL. Comparison of three common tonsillectomy techniques: a prospective randomized, double-blinded clinical study. Laryngoscope. 2009;119(1):162–170.

9. Jones DT, Kenna MA, Guidi J, Huang L, Johnston PR, Licameli GR. Comparison of postoperative pain in pediatric patients undergoing coblation tonsillectomy versus cautery tonsillectomy. Otolaryngol Head Neck Surg. 2011;144(6):972–977.

10. Based on internal test report #RE00015788, Tissue testing. March 23, 2017.

†Compared to the competitive closure device, suture passers, and hand sutures.

1. Based on internal validation report #RE00098009 Rev A, DoubleTime VersaOne™ fascial closure system Miami lab VOCreport: 13 out of 16 surgeons surveyed agreed. March 28, 2017.

Jaws Cool Faster. - Based on internal test report #RE00059406 Rev A, Market research - thermal profile comparison of LigaSure™ retractable L-hook (LF56XX) versus Harmonic Ace™*+7 and Olympus Thundebeat™* using the ForceTriad™ energy platform and Valleylab™ FT10 energy platform on porcine mesentery with 10 consecutive seal/cut cycles. Sept. 7, 2016.

Three Times Cooler - Based on internal test report #RE00059406 Rev A, Market research - thermal profile comparison of LigaSure™ retractable L-hook (LF56XX) versus Harmonic Ace™*+7 and Olympus Thundebeat™* using the ForceTriad™ energy platform and Valleylab™ FT10 energy platform on porcine mesentery with 10 consecutive seal/cut cycles. Sept. 7, 2016. / Harmonic Ace™* +7 on max mode and Olympus Thunderbeat™* on default setting 1 of seal/cut mode

Bringing Value with Versatility. / Redefining Versatility. - Based on internal test report #RE00041188, Validation marketing claims: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine labs. October 2015 and February 2016. / 29 out of 29 surgeons evaluated agreed / Based on internal test report #RE00032739 Rev A, Ligasure™ Hook (LF5637, LF5644) validation surgeon evaluation report: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine lab conducted in Houston, Texas. February 2016.

Fewer Instrument Exchanges. More Possibilities. - Based on internal test report #RE00041188, Validation marketing claims: independent surgeon feedback collected during Medtronic-sponsored cadaver and porcine labs. October 2015 and February 2016. / 27 out of 29 surgeons evaluated agreed / 29 out of 29 surgeons evaluated agreed

1. Morris TA, Gay PC, MacIntyre NR, Hess DR, Hanneman SK, Lamberti JP, Doherty DE, Chang L, Seckel MA. Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients. Respir Care. 2017 Apr;62(4):497-512.

2. Hodgetts TJ, Kenward G, Vlackonikolis I, et al. Incidence, location and reasons for avoidable in-hospital cardiac arrest in a district general hospital. Resuscitation. 2002;54(2):115-123.

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