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

Catalog Number	HARXX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Perforation (2001)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: chatroux lr, maghsoudlou p, ajao mo, king lp, einarsson ji.Bowel endometriosis excision: approaches and outcomes including hand sewing of discoid excision.J minim invasive gynecol.2024 nov;31(11):951-955.E1.Doi: 10.1016/j.Jmig.2024.07.019.Epub 2024 jul 31.Pmid: 39089645.This retrospective cohort study aims to assess the outcomes of laparoscopic bowel endometriosis excision, focusing on the comparison of excision type ¿ shaving, discoid excision with hand-sewn closure, and segmental resection - and their associated complication rates.Between 2009 to 2022, a total of 112 patients underwent laparoscopic excision of endometriosis involving the rectum.From this cohort, 82 underwent shaving, 23 underwent discoid excision, and 7 had segmental bowel resection while using harmonic scalpel (ees) and monocryl (eth).Reported complications are harmonic scalpel (ees).Monocryl (eth).Anastomosis leak (n=3).Treatment: not reported.Bowel perforation (n=5).Treatment: reoperation.Grade 1 clavien dindo complication (n=5).Treatment: not reported.Grade 2 clavien dindo complications (n=18) treatment: not reported.Grade 3b clavien dindo complications (n=6) treatment: not reported.In conclusion, our data shows a similar rate of anastomotic leak complication for each closure type as that reported in the literature (2.2%, 9.7% and 9.9% reported for shave, discoid and segmental resection respectively).While our study is underpowered, these findings support that hand sewing for discoid excision is a safe and reasonable alternative to circular stapler closures and can be considered with an experienced surgeon.Further study is warranted to confirm safety and explore potential cost savings associated with this technique as well as applications in areas with less resources available.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/29/2025.B3: publication year of 2024.D4: batch # unk.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.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
• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 22108723
• Report Number: 3005075853-2025-04042
• Device Sequence Number: 7657932
• Product Code: LFL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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: HARXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown