MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number	544965
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the sample was returned to the manufacturer for evaluation.The manufacturer reported: "per customer provided information the dhr for the alleged defective medical device was reviewed and found complete without any irregularities.The alleged defective instrument was produced at (b)(6) facility as part of a 50 pc.Lot in january of 2024 from lot number 06d2360035.The investigation determined that the manufacturing processes adhered to approved specifications, utilizing the correct materials and components.A thorough visual and functional inspection was conducted, revealing that the jaws and outer tube were misaligned and bent, leading to the rivet becoming dislodged.This malfunction resulted in the jaws detaching from the outer tube, causing misalignment that prevented proper loading of the clip, thereby rendering the device nonfunctional.While the exact cause of the misalignment and rivet dislodgement could not be conclusively identified, excessive force during use at the end user's facility is suspected.End of life for surgical instruments is normally determined by wear and damage due to the intended use or misuse.Even with proper handling, correct care, and maintenance; reusable instruments should not be expected to last indefinitely and should be replaced at any sign of wear and/or damage.Notably, all 50 instruments from this lot underwent 100% visual inspection and functional testing prior to shipment, in accordance with standard operating procedures for this product line.Due to these findings, no further actions will be taken in response to this complaint, and this record will be deemed closed." teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "a popped rivet was identified during repair at msi." no patient involvement.

• Brand Name: WECK HOL ML 5MM ENDO APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24795414
• Report Number: 3011137372-2026-00099
• Device Sequence Number: 8805891
• Product Code: GDO
• UDI-Device Identifier: 44026704727481
• UDI-Public: (01)44026704727481(11)240522(17)001231(10)06D2360035(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: 544965
• Device Lot Number: 06D2360035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown