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

Catalog Number 544250

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Event 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".

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

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 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
• Type of Device: 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
• MDR Text Key: 328764656
• Report Number: 3003898360-2023-01559
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704625216
• UDI-Public: 34026704625216
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544250
• Device Lot Number: 73B2200316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1