MAUDE Adverse Event Report: Ethicon Inc. LAPRA-TY; Clip, Implantable

Catalog Number	XC200
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: - please confirm if there is an issue with the applier? no issues.- what suture type and size was used? 3-0 stratafix or vloc.- when the event occurred, was the suture placed near the hinge of the clip? yes.- were you able to lock the clip closed on the suture? if yes, after it closed, was the clip holding securely fixed on the suture? eventually yes and yes.- was the applier checked for damaged (jaws straight and aligned)? no damage to clip applier.- if the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? the clip was not holding when loading until the tech got it to lock eventually.Yes to tension.Device history review: a manufacturing record evaluation was performed for the finished device 104p1h/xc20022 and no non conformances / manufacturing irregularities related to the malfunction were identified.Mfg.Date: 11/12/2024 expiry date: 10/31/2027.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture clips was used.The clips did not close properly during procedure.Used 4 packs from same lot.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: LAPRA-TY
• Common Device Name: Clip, Implantable
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.-San Angelo; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50921721
• Report Number: 2210968-2026-09785
• Device Sequence Number: 14784963
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K931492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: XC200
• Device Lot Number: 104P1H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown