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 Problems Pyrosis/Heartburn (1883); Inflammation (1932); Nausea (1970); Vomiting (2144); Insufficient Information (4580)

Event Date 08/12/2022

Event Type  Injury  

Event Description

Title: long-term outcomes of laparoscopic gastric plication for treatment of morbid obesity: a single-center experience.Author: mohamed abdelgawad · ahmed elgeidie · mohamed el sorogy · mohamed elrefai · hosam hamed · el-sayed abou el-magd.Citation: obesity surgery (2022) 32:3324¿3331 https://doi.Org/10.1007/s11695-022-06217-3.This study was conducted to elucidate the long-term consequences of laparoscopic gastric plication (lgp).Retrospective analysis of patients with obesity underwent lgp at our institution between march 2010 and september 2014.Of the 88 consecutive patients in the study, follow-up data out to 6 years was available in 60 lgp patients.The mean age of the included patients was 41.3 ± 10 years.Harmonic devices was used for devascularization.Prolene and/or ethibond sutures were used for plication.The following complications were reported as follows: (n=5) nausea, vomiting and epigastric pain.(n=?) de novo gerd.(n=4) erosive esophagitis, 3 of them had grade a reflux esophagitis, and the other one had grade b reflux esophagitis.(n=1) major complication and required emergency reoperation due to early leakage from the proximal one-third of the plicated gastric fundus.(n=13) reoperations.In conclusion, at the 6-year follow-up visit, lgp has a much less durable effect on weight loss with a % ewl of 32% and a weight regain of 58.3% resulting in a high rate of revisions.

Manufacturer Narrative

(b)(4).Date of event: 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.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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: 16643747
• MDR Text Key: 312306039
• Report Number: 3005075853-2023-02097
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention