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	03/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the "clip was found broken during usage on the patient".Additional information states that no part or clip fell/was retained inside the patient's body.No medical intervention needed.The patient status is reported as "fine".
Event or Problem Description
It was reported that the "clip was found broken during usage on the patient".Additional information states that no part or clip fell/was retained inside the patient's body.No medical intervention needed.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).As per the additional information received on 18 apr 2023, the clip did not fall into the patient's body.The applier would not be returned for investigation.No further requested information available.Complaint verification testing could not be performed as it was reported that the sample is not available for return.Part number 544240 is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process".The additional test was conducted as follows: 20 samples were taken from the current production part number 544243 hemolok l clips 3/cart 42/box, lot# 73e2300854, the samples were functionally inspected, and during the test issue reported "broken parts - clip - info not provided was not observed in the current manufacturing process.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16817248
• Report Number: 3003898360-2023-00651
• Device Sequence Number: 13917189
• Product Code: FZP
• UDI-Device Identifier: 24026704695939
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73A2200376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown