MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL APPLIER XL 11" RA; APPLIER, SURGICAL, CLIP

Model Number	IPN915179
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the user was unable to load a clip to the applier properly.Then he/she felt difficulty in ligation.After that the spring part of the applier got broken.Therefore, he/she replaced it with another applier (catalog #: 544191) to complete the procedure.No clip fell/remained in the patient.The applier was purchased by the hospital within 1 month, and it was the first time to use.
Event or Problem Description
It was reported that the user was unable to load a clip to the applier properly.Then he/she felt difficulty in ligation.After that the spring part of the applier got broken.Therefore, he/she replaced it with another applier (catalog #: 544191) to complete the procedure.No clip fell/remained in the patient.The applier was purchased by the hospital within 1 month, and it was the first time to use.
Additional Manufacturer Narrative
(b)(4) the dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha wi facility as part of a 24 pc.Lot in july of 2019.Evaluation of this instrument shows that the spring guide pin (p52338) is broken off of the single side of the handle thus not allowing the spring to stop on the handle so that the tips can retain the proper open jaw gap needed to successfully pick up and retain a clip.We are able to validate this complaint.Mishandling of this instrument at the end user's facility is suspected.All 24 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.

• Brand Name: HOL APPLIER XL 11" RA
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11413948
• Report Number: 3011137372-2021-00058
• Device Sequence Number: 19852811
• Product Code: GDO
• UDI-Device Identifier: 24026704696806
• UDI-Public: 24026704696806
• 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): 02/18/2021

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: IPN915179
• Device Catalogue Number: 544192
• Device Lot Number: 06C1866780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1