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	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The tip of the applier got broken in the patient while in use during laparoscopic hepatectomy.No parts/fragments were confirmed by x-ray after procedure.However, the user would like us to check if any parts are missing on the applier.
Event or Problem Description
The tip of the applier got broken in the patient while in use during laparoscopic hepatectomy.No parts/fragments were confirmed by x-ray after procedure.However, the user would like us to check if any parts are missing on the applier.
Additional Manufacturer Narrative
(b)(4).During visual and functional examination, we found the following: the pull rod is bent and the joint for the mouthpieces is broken.Color marking at pull rod is strongly deformed.All parts of the broken linkage systems we received back; no part is missing.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.100% functional test at final inspection found good.The root cause: excessive force to the handle during use.At k & w, no further measures will be initiated; this complaint is being rejected by us.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11706660
• Report Number: 3011137372-2021-00124
• Device Sequence Number: 14237489
• Product Code: GDO
• UDI-Device Identifier: 24026704697841
• UDI-Public: 24026704697841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/14/2021

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: N0-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1