MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 3/CART 42/BOX; CLIP, IMPLANTABLE

Catalog Number 544243

Device Problem Break (1069)

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

Event Date 12/26/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#1900098672 the device history review for the hemolok l clips 3/cart 42/box lot# 73e2200864 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that on (b)(6)2022 , a clip was found broken when clipped by appiler.No applier will be return.

Manufacturer Narrative

(b)(6)the customer returned one loose clip from unit 544253 hemolok xl clips 3/cart 42/box.The loose clip was visually examined with and without magnification.Both pierced bosses were broken off the loose clip.R and d was consulted about the broken clip and the clip breaking at the pierced bosses.The documented root cause is a lack of specifications around boss requirements leading to insufficient controls of porosity/run-times at the supplier.A capa has been previously opened to further investigate issues related to clip breakages.Functional inspection could not be performed due to the damage on the returned clip.The device history review for the hemolok l clips 3/cart 42/box lot# 73e2200864 investigation did not show issues related to the complaint.The ifu for this product, l02425, 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." the returned loose clip was broken at the pierced bosses which is due to a lack of specifications around boss requirements leading to insufficient controls of porosity/run-times at the supplier.This is a design related issue.The reported complaint of brok en/detached parts-clip-boss was confirmed based upon the sample received.

Event Description

It was reported that on (b)(6) 2022, a clip was found broken when clipped by appiler.No applier will be return.

• Brand Name: HEMOLOK L CLIPS 3/CART 42/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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16126644
• MDR Text Key: 307986327
• Report Number: 3003898360-2023-00091
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544243
• Device Lot Number: 73E2200864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED