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

Catalog Number	544250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during open nephrectomy surgery, the clip broke after it was locked".The clip and any fragments were removed it their entirety from the patient.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4), failure mode "broken parts - clip - info not provided" could be confirmed with picture attached.However, it is necessary to receive the physical sample to perform a proper investigation, determinate the root cause & corrective actions.A device history record review was performed, and no relevant findings were identified.If the complaint samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported that "during open nephrectomy surgery, the clip broke after it was locked".The clip and any fragments were removed it their entirety from the patient.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: HEMOLOK XL 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18185849
• Report Number: 3003898360-2023-01559
• Device Sequence Number: 6541633
• Product Code: FZP
• UDI-Device Identifier: 34026704625216
• UDI-Public: 34026704625216
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 11/17/2023

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 Catalogue Number: 544250
• Device Lot Number: 73B2200316
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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