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

Model Number	IPN915184
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device investigation is pending, and the results will be submitted in a follow-up report.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that on ((b)(6)2020, a clip was found broken during lateral prostatic ligament ligation.It involved one piece.Another clip was used.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one broken clip from (b)(4) unit of 544240 hemolok l clips (b)(4)/cart (b)(4)/box for investigation.The broken clip was visually examined with and without magnification.Visual examination revealed that the clip was broken at the hook leg near the hook bosses.The sample appeared used as there was biological material on the cartridge.The root cause for the broken leg could not be determined.There are no indications that the leg broke due to a manufacturing issue.It is possible that the leg broke due to improper loading or by using damaged/misaligned appliers, but this could not be confirmed due to the limited complaint information provided.The appliers were not returned for investigation.A dimensional inspection was not required as a part of this complaint investigation and a functional inspection could not be performed due to the damage to the returned clip.The device history review for the product hemolok l clips (b)(4)/cart (b)(4)/box lot# 73e2200559 investigation did not show issues related to complaint.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 function.A corrective action is not required at this time as the root cause could not be determined.Teleflex will continue to monitor and trend on complaints of this nature.The reported complaint of broken/detached parts - clip - leg was confirmed based upon the sample received.A clip was returned broken at the hook leg near the hook bosses.It is unknown how the returned clips were handled during use and the appliers were not returned for investigation.Therefore, based upon the damage observed and the information provided, the root cause could not be determined.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that on 11 nov 2020, a clip was found broken during lateral prostatic ligament ligation.It involved one piece.Another clip was used.

• Brand Name: HEMOLOK L 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15915908
• Report Number: 3003898360-2022-00751
• Device Sequence Number: 14569762
• Product Code: FZP
• UDI-Device Identifier: 44026704695933
• UDI-Public: 24026704695939
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73E2200559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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