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

Model Number IPN915182

Device Problem Break (1069)

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

Event Date 08/29/2022

Event Type  malfunction  

Event Description

It was reported that a clip was broken at ligation during surgery.The clip fell from the applier, but it was immediately removed from the patient's body.No medical intervention was required.Additional information/correction: it was confirmed that the clip was broken at loading, not at ligation.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The customer returned one cartridge with four intact clips and two broken clips from one unit 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 both broken clips were broken in half at the hinge.The hook halves were returned loose.The pierced boss halves were returned in the cartridge.No defects or anomalies were observed on the other clip.No clear evidence of use in the form of biological material was observed on the returned clips.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 breakages.Dimensional inspection was not required as a part of this complaint investigation.Functional inspection was performed on the intact clips that were returned.No defects or anomalies were observed with the returned intact clips.Additional testing was not required as a part of this complaint investigation.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73l2100595 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." both returned broken clips were broken at the hinge during loading.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.In conclusion, the reported complaint of "broken/detached parts - clip - hinge" was confirmed based upon the sample received.Two broken clips were returned, and both were broken at the 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

It was reported that a clip got broken at ligation during surgery.The clip fell from the applier, but it was immediately removed from the patient's body.No medical intervention was required.Additional information/correction: it was confirmed that the clip was broken at loading, not at ligation.

• 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: 15788405
• MDR Text Key: 306563185
• Report Number: 3003898360-2022-00738
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73L2100595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention