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

Catalog Number	544965
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "a popped rivet was identified during repair at msi." no patient involvement.
Additional Manufacturer Narrative
(b)(4).The reported issue 'popped rivet' was confirmed upon investigation of the returned sample.The complaint device was received at our manufacturing site for investigation.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.A device history record review was performed, and no relevant findings were identified.The investigation determined that the manufacturing processes adhered to approved specifications, utilizing the correct materials and components.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.No further actions are required at this time.
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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23694986
• Report Number: 3011137372-2025-00418
• Device Sequence Number: 21130466
• 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 State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 11/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown