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

Catalog Number	544965T
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	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the first three clips were ligated to the right branch of the right colic artery without problem during an ascending colectomy.When the user was ligating probably the fourth clip, the applier got broken and some foreign material was seen flying off through the monitor.The clip was in a closed condition.The applier was taken out of the abdominal cavity and confirmed that the jaws were broken.The inside the abdominal cavity was searched and a metal piece, supposedly the broken piece of the applier, was withdrawn.The applier was replaced with another applier to complete the procedure.No injury to the patient occurred.".
Event or Problem Description
It was reported that "the first three clips were ligated to the right branch of the right colic artery without problem during an ascending colectomy.When the user was ligating probably the fourth clip, the applier got broken and some foreign material was seen flying off through the monitor.The clip was in a closed condition.The applier was taken out of the abdominal cavity and confirmed that the jaws were broken.The inside the abdominal cavity was searched and a metal piece, supposedly the broken piece of the applier, was withdrawn.The applier was replaced with another applier to complete the procedure.No injury to the patient occurred.".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "the instrument w/ lot q3 was shipped to tfx with invoice # (b)(4) of 2023/05/24 and original manufacturing lot is 22340694 dhr review: upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.Pull rod was bent and pin got broken due to too much force with the handle.At k & w no further measures will be initiated; this complaint is being rejected by us." teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: WECK HEMOLOK TAKEAPART 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24513143
• Report Number: 3011137372-2026-00057
• Device Sequence Number: 18705695
• Product Code: GDO
• UDI-Device Identifier: 24026704697841
• UDI-Public: (01)24026704697841(11)230524(17)001212(10)Q32340694(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/10/2026

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: 544965T
• Device Lot Number: Q32340694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown