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

Catalog Number 544230

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

A clip fell from the instrumental applier during a robot-assisted laparoscopic operation.Therefore, a new cartridge was used instead.The same issue occurred to another operation.

Manufacturer Narrative

Qn#(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73f2100973 investigation did not show issues related to the complaint.

Manufacturer Narrative

Qn# (b)(4).The customer returned two loose clips of 544230 hemolok ml clips 6/cart 84/box for investigation.The returned clips were visually examined with and without magnification.Visual examination revealed that one loose clip was broken at the inner hinge.No defects or anomalies were observed on the other clip.Signs of use in the form of biological material were observed on the returned clips.The clip breaking 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.Functional inspection was performed on the intact clip that was returned.The intact clip was manually loaded into a lab inventory a pplier and was successfully applied to over-stressed surgical tubing without breaking.No defects or anomalies were observed with the returned intact clip.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." one of the returned clips was broken at the inner hinge during ligation.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 reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.A broken clip was returned, and it was broken at the inner hinge.The clip 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.

Event Description

A clip fell from the instrumental applier during a robot-assisted laparoscopic operation.Therefore, a new cartridge was used instead.The same issue occurred to another operation.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14643418
• MDR Text Key: 301355121
• Report Number: 3003898360-2022-00242
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2022

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 Catalogue Number: 544230
• Device Lot Number: 73F2100973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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