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

Model Number	IPN915182
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73f2200473 investigation did not show issues related to the complaint.
Event or Problem Description
Reported issue: on (b)(6)2023, the clip was found broken during usage on the patient.There was one piece involved.Another clip was used and there was no reported injury.
Event or Problem Description
Reported issue: on (b)(6) 2023, the clip was found broken during usage on the patient.There was one piece involved.Another clip was used and there was no reported injury.
Additional Manufacturer Narrative
(b)(4).The customer returned two loose broken clip halves, one loose intact clip, and one cartridge with two clips remaining from one unit of 544230 hemolok ml clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Visual examination revealed that the broken clip was broken in half at the hinge.Evidence of use in the form of biological material was observed on the returned sample.Scrape marks and gouging were observed on the returned cartridge.The bottom of the cartridge was observed to be torn.The pierced boss and hook leg of the intact clip appeared to be damaged during use.No other defects or anomalies were observed.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.The loose intact clip and both clips remaining in the cartridge were loaded into lab inventory a ppliers and successfully applied to overstressed surgical tubing without breaking.Functional testing could not be performed on the broken clip because it was broken in half at the hinge.Per dhr the product hemolok ml clips 6/cart 84/box lot# 73f2200473 was manufactured on 06/14/2022 a total of 15,008 pieces.Lot was released on 06/21/2022.Dhr 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 returned broken clip was broken at the 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.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 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.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16549862
• Report Number: 3003898360-2023-00351
• Device Sequence Number: 5993528
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73F2200473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown