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	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture clip was used.The clip could not be loaded into an applier properly.The clip could not be deployed.Another device was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) the following information was requested, but unavailable: please provide the applier product code and lot number? unk.Please explain how the clips were loading into the applier? unk please confirm if the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading ? unk.Additional information was requested, and the following was obtained: were you able to lock the clip closed on the suture? no please confirm if there is an issue with the applier? no was the applier checked for damaged (jaws straight and aligned)? no h3 investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample revealed that the xc200 cartridge (a) was received opened with 4 clips loaded and with no apparent damage.In addition, an opened foil was received along with the device.In an attempt to replicate the reported incident, the clips were tested for functionality with a test device.Upon functional testing of the reload, the instrument loaded, retained, and deployed 4 clips as intended over the suture.The clips were fully functional and conforming.The event described could not be confirmed as the clips performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review a manufacturing record evaluation was performed for the finished device 10b81b/xc20022 and no non conformances/manufacturing irregularities related to the malfunction were identified.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: 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: 50944706
• Report Number: 2210968-2026-09896
• Device Sequence Number: 18753489
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 10B81B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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