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	03/03/2026
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 clips were used.During the procedure, it was reported by a sales rep that, during an unknown surgery, when the hospital attempted to connect the clips by the applier, it was found that the clip in the clip cartridge was broken.Another device was used to complete the case.There were no adverse consequences to the patient.Visual analysis of the returned sample determined that the xc200 cartridge was received empty, along with the clips broken inside of a plastic jar.In addition, the foil was examined and showed multiple wrinkles and small holes on the bottom cavity of the foil package related possibly to excessive manipulation.No further information is available.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: visual analysis of the returned sample determined that the xc200 cartridge was received empty, along with the clips broken inside of a plastic jar.In addition, the foil was examined and showed multiple wrinkles and small holes on the bottom cavity of the foil package related possibly to excessive manipulation.The product code xc200 contains absorbable clips and as the sample was received open the degradation process had already begun, the time of exposure to the environment could not be determined and no functional test can be performed due to sample condition.The event report could not be confirmed as the cartridge was received with the clips broken.It should be noted that all ethicon product is 100% inspected prior to release.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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 ; 3035526892
• MDR Report Key: 25083714
• Report Number: 2210968-2026-04891
• Device Sequence Number: 10532953
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: (01)10705031206885(17)260331(10)TD2ABJ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: XC200
• Device Lot Number: TD2ABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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