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

Model Number	IPN915197
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
The jaws of the applier were found misaligned upon opening the kit.The user tested the applier, but it was difficult to load a clip and the clip did not easily leave the applier.Therefore, a new unit was used instead.
Event or Problem Description
The jaws of the applier were found misaligned upon opening the kit.The user tested the applier, but it was difficult to load a clip and the clip did not easily leave the applier.Therefore, a new unit was used instead.
Additional Manufacturer Narrative
(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was originally produced at the manufacturing facility as part of a 50 pc.Lot in december of 2021.Evaluation of the returned instrument as received shows that the tips of the jaws are aligned in the open and closed position.Functional testing of this instrument was performed, and it is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing.There were no non-conforming features found on this device.We are unable to validate this complaint.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.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15362879
• Report Number: 3011137372-2022-00179
• Device Sequence Number: 5124650
• Product Code: GDO
• UDI-Device Identifier: 24026704696837
• UDI-Public: 24026704696837
• 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): 08/23/2022

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: IPN915197
• Device Catalogue Number: 544995
• Device Lot Number: 06J2140658
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sex: Unknown