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	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 clip was found broken prior to the patient.1 cartridge involved.
Additional Manufacturer Narrative
(b)(4).The device history review for the product hemolok med clips 6/cart 84/box ,lot# 73f2100960.Investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).Per dhr the product hemolok med clips 6/cart 84/box lot# 73f2100960 was manufactured on 06/29/2021 a total of (b)(4) pieces.Lot was released on 07/20/2021.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544220 hemolok med clips 6/cart 84/box for investigation.One loose clip was also returned.The loose clip and cartridge were both visually examined with and without magnification.Visual examination revealed that the cartridge was returned with the hook half of a clip, three broken pierced bosses, and multiple pieces of the cartridge that had been scraped off all remaining in the cartridge.The clip was broken on the hook side of the hinge.The loose clip had its pierced bosses broken off.Multiple fingers on the cartridge were damaged.Multiple scrape marks were observed on both broken clips and the cartridge.R & d engineering was consulted for this complaint.The damages observed to the cartridge and clips are indicative of improper loading technique or that damaged/misaligned appliers were used on the clips.The ifu for this product, l02425, 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." a corrective action is not required at this time as the damage observed on the clip and cartridge indicates that unintentional user error caused or contributed to this event.The reported complaint of "broken clip - multiple locations" was confirmed based upon the sample received.One cartridge was returned with half of a broken clip and three broken pierced bosses remaining in the cartridge.One loose clip with its pierced bosses broken off was also returned.The broken clip in the cartridge was broken on the hook side of the hinge.Multiple fingers on the cartridge were damaged.Multiple scrape marks were observed on both broken clips and the cartridge.The damages observed to the cartridge and clips are indicative of improper loading technique or that damaged/misaligned appliers were used on the clips.It is unknown how the returned clips were handled during use and the appliers used at the time of malfunction were not returned for investigation.A device history record review was performed on the device and showed no evidence to suggest a manufacturing related issue.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
(b)(6) 2021 clip was found broken prior to the patient.1 cartridge involved.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12934694
• Report Number: 3003898360-2021-01073
• Device Sequence Number: 14691852
• Product Code: FZP
• UDI-Device Identifier: 24026704695908
• UDI-Public: 24026704695908
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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: 06/28/2026
• Device Model Number: IPN915181
• Device Catalogue Number: 544220
• Device Lot Number: 73F2100960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown