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

Model Number	IPN915197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
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
The handle of the applier got detached during a pretest before use.Therefore, a new unit was used instead.The applier was purchased by the hospital in (b)(6) 2020.
Additional Manufacturer Narrative
Qn# (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 50 pc.Lot in september of 2019.Evaluation of the returned instrument shows that the distal handle (g00388) and pivot screw (n00186) are loose from the instrument.Further evaluation shows that there are (3) staking marks on both the g00436m handle and the bottom of the n00186 screw signifying that this instrument has been properly staked at the time of manufacture.We are able to validate this complaint.After the initial evaluation this instrument was re-assembled , and its function was tested , and it was able to pick-up, retain , close and release multiple clips both with and without the use of silastic test tubing.Mishandling or tampering of this instrument 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.
Event or Problem Description
The handle of the applier got detached during a pretest before use.Therefore, a new unit was used instead.The applier was purchased by the hospital in (b)(6) 2020.

• Brand Name: HOL L 10MM ENDO APPLIER
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11693622
• Report Number: 3011137372-2021-00108
• Device Sequence Number: 3511503
• 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): 04/08/2021

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: 06A1982814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1