MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HEMOLOK MED CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Catalog Number	544220
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "clamps failed.We have had an increased number of failed vasectomies with the use of this lot number in particular".Additional information received on january 21, 2026, indicated that "the failure was related to clip loading/seating issues and ligation failure.The patient required a second vasectomy and had to visit the emergency room (er) due to a large hematoma, after the clip had to be clamped multiple times.The patient's current condition is fine, but frustrated." three patients were involved.Associated mdrs: 3003898360-2026-00067 and 3003898360-2026-00066.
Event or Problem Description
It was reported that "clamps failed.We have had an increased number of failed vasectomies with the use of this lot number in particular".Additional information received on january 21, 2026, indicated that "the failure was related to clip loading/seating issues and ligation failure.The patient required a second vasectomy.The patient's current condition is fine, but frustrated." three patients were involved.Associated mdrs: 3003898360-2026-00065, 3003898360-2026-00067, and 3003898360-2026-00066.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: section b.Describe event or problem: changed from: "additional information received on january 21, 2026, indicated that "the failure was related to clip loading/seating issues and ligation failure.The patient required a second vasectomy and had to visit the emergency room (er) due to a large hematoma, after the clip had to be clamped multiple times.The patient's current condition is fine, but frustrated." to: additional information received on january 21, 2026, indicated that "the failure was related to clip loading/seating issues and ligation failure.The patient required a second vasectomy.The patient's current condition is fine, but frustrated.".

• Brand Name: WECK HEMOLOK MED CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24274160
• Report Number: 3003898360-2026-00065
• Device Sequence Number: 9948278
• Product Code: FZP
• UDI-Device Identifier: 14026704725691
• UDI-Public: (01)14026704725691(11)250602(17)300601(10)73E2501040(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K232970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 544220
• Device Lot Number: 73E2501040
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown