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

Model Number IPN915182

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history review could not be conducted since the lot number provided is not a valid number.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the hemolok's snapping during intended action in the abdomen.The action taken was reported as noted the batch numbers and switched to a different lot number.

Event Description

It was reported that the hemolok's snapping during intended action in the abdomen.The action taken was reported as noted the batch numbers and switched to a different lot number.

Manufacturer Narrative

(b)(4).The customer returned one lidstock and one cartridge from one unit of 544230 hemolok ml clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Biological material was observed on the returned cartridge.Two pierced boss and one hook clip halves were discovered within the returned cartridge.No other defects or anomalies were observed.Visual examination revealed that the broken clips were broken in half at the hinge.Evidence of use in the form of biological material was observed on the returned sample.The clips breaking at the hinge during loading 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 bre akages.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73m2100245 investigation did not show issues related to complaint.The ifu for this product, l02425 rev.02, 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 reported complaint of broken/detached parts - clip - hinge was confirmed based upon the sample received.Three broken clip halves were returned, and all were broken at the hinge.The clips breaking at the hinge during loading 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.

• Brand Name: HEMOLOK ML 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15760996
• MDR Text Key: 306238133
• Report Number: 3003898360-2022-00666
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 200138W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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