MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number	544995
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " that the jaws of the applier did not open/close even though grasping the handle during the test before use.Therefore, another applier was used instead".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "the dhr for the returned instruments were re viewed and found complete without any irregularities.This instrument was produced at the tecomet, kenosha, wi facility as part of a 50-pc.Lot in july of 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instruments shows that the tips are bent to the right and do not move when the handle to jaw mechanism is activated.We are able to validate this complaint for the returned instrument.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the end of the drive rod that actuates the slots in the jaws is twisted/damaged and broken off from the rest of the drive rod.We are unable to determine what caused the end of the drive rod to become twisted/damaged and broken off from the rest of the drive rod but mishandling such as excessive force being applied to the handle to jaw mechanism on this device at the end user's facility is suspected.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HOL L 10MM 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19279725
• Report Number: 3011137372-2024-00075
• Device Sequence Number: 18057350
• Product Code: GDO
• UDI-Device Identifier: 34026704623649
• UDI-Public: 34026704623649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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
• Device Catalogue Number: 544995
• Device Lot Number: 06A2244781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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