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

Model Number IPN915184

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2023

Event Type  malfunction  

Event Description

Reported event: while attempting to apply clips on a vessel, the applier did not release the clip.Three appliers were used with the same results.We tried with several cartridges from the same lot number 73e2100914, and the clips would not release.We changed the lot number of the cartridge and it all worked properly.There was no patient injury.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok l clips 6/cart 84/box lot# 73e2100914 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).The customer returned nine unopened representative cartridges of 544240 hemolok l clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.No defects or anomalies were observed on the cartridges.The clips were loaded into lab inventory appliers, and application of each clip to overstressed surgical tubing was attempted.The clips returned clips could not consistently close on the first attempt.R & d engineering was consulted for this complaint and participated in functional testing.Per r & d, the root cause of the clips failing to latch on the first attempt could not be conclusively determined.A device history record review was performed and no relevant findings were identified.The ifu for this product 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." the reported complaint was confirmed based upon the sample received.R & d engineering was consulted and participated in functional testing for this complaint.According to r & d, the root cause of the clips failing to properly latch on the first attempt could not be conclusively determined.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Reported event: while attempting to apply clips on a vessel, the applier did not release the clip.Three appliers were used with the same results.We tried with several cartridges from the same lot number 73e2100914, and the clips would not release.We changed the lot number of the cartridge and it all worked properly.There was no patient injury.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16264769
• MDR Text Key: 308489570
• Report Number: 3003898360-2023-00204
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695939
• UDI-Public: 24026704695939
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73E2100914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED