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

Catalog Number 544233

Device Problem Break (1069)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

Hemolok was broken during use on surgery.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok ml clips 3/cart 42/box lot# 73f2100268 investigation did not show issues related to the complaint.

Manufacturer Narrative

Qn#(b)(4).The customer returned one cartridge with one broken clip from one unit of 544233 hemolok ml clips 6/cart 42/box for investigation.The returned components were visually examined with and without magnification.Visual examination revealed that the loose clip was broken in half at the hinge.Small scrapes were observed on the returned cartridge.No other defects or anomalies were observed.Evidence of use in the form of biological material was observed on the returned clip.The clip breaking in half at the hinge during ligation was determined to be the result of insert mismatch at the hinge area of the clip.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.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." in summary, the reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.A broken clip was returned, and it was broken in half at the hinge.The clip breaking at the hinge during ligation was determined to be the result of insert mismatch at the hinge area on the pierce leg side of the hinge.The root cause is due to inadequate specifications for insert mismatch in the highest stress area of the hinge, which is a design related issue.A capa has been previously opened to further investigate issues related to clip breakages.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Hemolok was broken during use on surgery.

• Brand Name: HEMOLOK ML 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15279370
• MDR Text Key: 304982095
• Report Number: 3003898360-2022-00404
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544233
• Device Lot Number: 73F2100268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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