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	12/15/2021
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
Applier misaligned.Product will be returned for repair so there is no return for investigation.
Event or Problem Description
Applier misaligned.Product will be returned for repair so there is no return for investigation.
Additional Manufacturer Narrative
(b)(4).Per customer provided information the dhr for the alleged instrument was reviewed and found complete without any irregularities.The alleged instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50 pc.Lot in (b)(6) of 2020.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alledged defect or validate the alleged complaint.All 50 instruments from this lot were 100% visually inspected and funtion 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 13053011
• Report Number: 3011137372-2021-00351
• Device Sequence Number: 16546555
• Product Code: GDO
• UDI-Device Identifier: 24026704696837
• UDI-Public: 24026704696837
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: IPN915197
• Device Catalogue Number: 544995
• Device Lot Number: 06B2098683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown