MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 01/06/2022

Event Type  Death  

Event Description

Title: sleeve gastrectomy performed with single staple height and bioabsorbable reinforcement in a single surgeon > 2500 consecutive case series: is smart technology necessary?.Author: george e.Woodman, guy r.Voeller.Citation: obesity surgery (2022) 32:690¿695 https://doi.Org/10.1007/s11695-021-05880-2.This retrospective chart review included 2556 consecutive cases of adult patients who underwent sleeve gastrectomy (january 2010 through december 2020) from a single surgeon at two community-based medical facilities.Patients were a mean age of 42 years, 87.3% were female, and the mean preoperative weight was 134.2 kg and bmi was 48.2 kg/ m2.Mobilization of the greater curvature is performed with a harmonic scalpel (ethicon endo-surgery, cincinnati, oh).In this case series, the ethicon flex staple was initially used, and then the ethicon powered stapler was used.Reported complications included bleeding events occurred (n=3) , death related to one of the two open procedures the patient experienced a pulmonary embolism and died 2 weeks postoperatively.(n=1).In conclusion in this case series of 2556 consecutive lsg performed by a single surgeon, clinically meaningful ewl and decreased bmi were achieved.Streamlining the lsg procedure by utilizing the same staple height and a bioabsorbable staple line reinforcement proved safe with minimal complications.

Manufacturer Narrative

(b)(4).: date of death unknown.Publication year of 2022.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.Would the surgeon be interested in speaking with ethicon medical and engineering personnel? does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.Does the author/surgeon believe that there is an alleged deficiency with the ethicon device that may have caused or contributed to the patients death in any way? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15698792
• MDR Text Key: 302689508
• Report Number: 3005075853-2022-07383
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death