MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Model Number	IPN915191
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use in a laparoscopic cholecystectomy, the pin in the jaw sheared breaking into pieces.All pieces were removed from the patient and confirmed using a-ray.There was no injury to the patient.The surgeon is an experienced user of hemolok.It was confirmed by the surgeon that the device was being used on the cystic duct and another 5mm hemolok clip applicator was used to finish the procedure.
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
(b)(4).The supplier investigation reported that upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.It was also reported by the supplier that during visual examination we found the following: under the microscope, the pin can be seen to have been torn out of the joint.The pin is completely present and 100% functional test at final inspection found good.In conclusion the supplier investigation determined that too much force was applied to the handle, causing the pin to be torn from the joint.No further measures will be initiated.
Event or Problem Description
It was reported that during use in a laparoscopic cholecystectomy, the pin in the jaw sheared breaking into pieces.All pieces were removed from the patient and confirmed using a-ray.There was no injury to the patient.The surgeon is an experienced user of hemolok.It was confirmed by the surgeon that the device was being used on the cystic duct and another 5mm hemolok clip applicator was used to finish the procedure.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15621012
• Report Number: 3011137372-2022-00197
• Device Sequence Number: 6225288
• Product Code: GDO
• UDI-Device Identifier: 24026704697841
• UDI-Public: 24026704697841
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/03/2022

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: IPN915191
• Device Catalogue Number: 544965T
• Device Lot Number: P2100557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown