MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY COMBO HOOK BLADE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	SNGHK2
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: publication year of 2014.Medical device: batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.
Event or Problem Description
Title: quicker yet safe: skeletonization of 1640 internal mammary arteries with harmonic technology in 965 patients.Author: teresa m.Kieser, m.Sarah rose, uthman aluthman and kishan narine.Citation: european journal of cardio-thoracic surgery 45 (2014) e142¿e150 / doi:10.1093/ejcts/ezu024.The purpose of this retrospective analysis of prospectively collected data was to compare major adverse cardiac events (maces) related to ima grafting between non-harmonic scalpel (hs) and hs patients, and compare times of harvest between non-hs harvest and hs harvest.From july 2003 to july 2013, a total of 1051 patients with isolated coronary artery bypass graft (cabg) were included in the study.Ima conduits were harvested in a skeletonized manner either with the traditional skeletonization technique (with use of the cautery tip without power as a dissector) (n=86, n=22 female, mean age 67.7 years) or with an ultrasonic scalpel (harmonic scalpel; ethicon endo-surgery) (n=965, n=206 female, mean age 64.7 years).In harmonic scalpel group, the harmonic scalpel was used to isolate and free the ima, from its distal bifurcation into the superior epigastric and musculophrenic branches to proximally above the first intercostal branch.In the harmonic technique, branches were sealed using the blunt end of the harmonic device.Postoperative complication included deep sternal wound infection (n=15).In this largest series to date of harmonic ima skeletonization, this technique results in rare damage, is quicker and with a comparable adverse event rate compared with the non-harmonic method.

• Brand Name: HS SYNERGY COMBO HOOK BLADE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9386033
• Report Number: 3005075853-2019-23815
• Device Sequence Number: 2403277
• Product Code: LFL
• UDI-Device Identifier: 10705036013815
• UDI-Public: 10705036013815
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SNGHK2
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SNGHK2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other