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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During surgery, the clip could be loaded into an applier properly three packs in a row, but the clip was not fed into the jaws properly.Same device was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: did the reported issue contribute to any patient adverse consequences? no.Please provide the applier product code and lot number? ka200.Please confirm if there is an issue with the applier? no.Was the applier checked for damaged (jaws straight and aligned)? no.The following information was requested, but unavailable: could you please provide the lot number? unk.Package lot number of the clips? 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50896780
• Report Number: 2210968-2026-09679
• Device Sequence Number: 6026497
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: 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): 09/25/2026

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
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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