MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK TAKEAPART ENDO ML APPLIER 20-DEG; APPLIER, SURGICAL, CLIP

Model Number	IPN028386
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
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 applier broke during use.There was no consequence for the patient.The incident happened at the digestive surgery room on (b)(6) 2021.No parts of the broken device fell inside the patient.
Event or Problem Description
The applier broke during use.There was no consequence for the patient.The incident happened at the digestive surgery room on (b)(6) 2021.No parts of the broken device fell inside the patient.
Additional Manufacturer Narrative
(b)(4).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.During visual and functional examination we found the following: pull rod broken/bent/deformed.Color marking at pull rod deformed and broken as a result of too much pressure with the handle.Over all, the instrument was poorly cleaned, there was still dried blood on the pull rod.All parts are received back.No further measures will be initiated.

• Brand Name: HEMOLOK TAKEAPART ENDO ML APPLIER 20-DEG
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12135437
• Report Number: 3011137372-2021-00174
• Device Sequence Number: 4180340
• Product Code: GDO
• UDI-Device Identifier: 24026704697858
• UDI-Public: 24026704697858
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/29/2021

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 Expiration Date: 01/31/2021
• Device Model Number: IPN028386
• Device Catalogue Number: 544965T20
• Device Lot Number: J5-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1