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

Model Number	IPN928366
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Alteration in Body Temperature (4568)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned three sealed representative cartridges of 544240 hemolok l clips 6/cart 84/box for investigation.The clip cartridges and clips were visually examined without magnification.Visual examination of the returned cartridges revealed that there were 6 correctly seated clips in each of the cartridges.There was no evidence of use in the form of biological material that was observed on the cartridges.No defects or anomalies were observed on the samples.Functional inspection was performed on the returned representative samples.A lab inventory clip applier was used.The clips from all three cartridges were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.The returned clips were not observed to reopen or migrate.No functional issues were found with the returned clips.Per dhr the product hemolok l clips 6/cart 84/box lot# 73b2500535 was manufactured on 02/21/2025 a total of (b)(4) pieces.Lot was released on 02/28/2025.Dhr investigation did not show issues related to complaint.The ifu for this product was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." a corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of clip migrates - other could not be confirmed based upon the sample received.The customer returned three sealed representative cartridges of 544240 hemolok l clips 6/cart 84/box for investigation.Upon functional inspection, all clips in the three cartridges were able to properly load into the jaws of a lab inventory applier and were successfully applied to over-stressed surgical tubing.None of the latched clips were observed to reopen or migrate.No damage was observed to any of the returned clips.No functional issues were found with the returned clips; therefore, the reported issue could not be confirmed.The probable cause of the reported complaint defect could not be determined based upon the information provided and without the actual sample.Additionally, a device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.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, "there were 3 clips, hemolok clip and metal clip that were applied on the renal artery of a living donor.The clips slipped and out of the three clips only one remained.The hemorrhage was controlled and the suture was done with a thread".No report of patient harm or injury.The patient status is reported as "fine".

• Brand Name: WECK HEMOLOK L 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 24377059
• Report Number: 3003898360-2026-00076
• Device Sequence Number: 20226980
• Product Code: FZP
• UDI-Device Identifier: 14026704725721
• UDI-Public: (01)14026704725721(11)250221(17)300220(10)73B2500535(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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 Model Number: IPN928366
• Device Catalogue Number: 544240
• Device Lot Number: 73B2500535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 72 KG