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

Model Number	IPN915181
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: some clips got broken at clip legs at ligation during a surgery.The name of the surgery is unknown.It is unknown what vessel was being ligated.No fragments fell in the patient's body.The operation was completed, and no additional cartridge was needed.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one picture for analysis.Visual examination of the customer photo identified there were three loose broken clips.The loose clips were broken at the hook side leg.The customer also returned one cartridge and 3 loose broken clips of 544220 hemolok med clips 6/cart 84/box for investigation.The cartridge and the loose clips were visually examined with and without magnification.Scrape marks were observed inside the cartridge.There were 2 intact clips remaining in the cartridge.The loose clips were broken at the hook side leg.Functional inspection was performed on the returned intact clips in the cartridge.The clips were able to load into the lab inventory applier and were successfully applied to over-stressed surgical tubing.No functional issues were observed with the returned intact clips.A device history record review was performed and no relevant findings were identified.The ifu for this product 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." "do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily.Remove the applier from the cartridge ensuring the clip is held securely in the applier jaws.It may be necessary to hold the cartridge to allow the clip to be removed." the reported complaint was confirmed based on the sample received.Scrape marks were observed inside the cartridge.Three clips were broken on the hook side leg.The cartridge was returned with two intact clips remaining.Upon functional inspection, the intact clips were able to load properly into a lab inventory applier and were successfully applied to overstressed surgical tubing.It could not be determined what exactly caused the observed defects.It is possible that the observed damage to the broken clips is from improper loading of the clips or by using damaged appliers.However, this could not be confirmed since the appliers were not returned for investigation.Therefore, the root cause for this complaint issue is undetermined.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported event: some clips got broken at clip legs at ligation during a surgery.The name of the surgery is unknown.It is unknown what vessel was being ligated.No fragments fell in the patient's body.The operation was completed, and no additional cartridge was needed.

• Brand Name: HEMOLOK MED 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16326939
• Report Number: 3003898360-2023-00102
• Device Sequence Number: 7843527
• Product Code: FZP
• UDI-Device Identifier: 24026704695908
• UDI-Public: 24026704695908
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/10/2023

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 Expiration Date: 07/14/2026
• Device Model Number: IPN915181
• Device Catalogue Number: 544220
• Device Lot Number: 73G2100516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown