MAUDE Adverse Event Report: TELEFLEX MEDICAL HOR ENDO CLIP APPLIER MED-LG; APPLIER, SURGICAL, CLIP

Model Number	IPN914987
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
The loaded clip got stuck and did not leave the applier during a surgery.Therefore, the user replaced the applier with a new unit.
Event or Problem Description
The loaded clip got stuck and did not leave the applier during a surgery.Therefore, the user replaced the applier with a new unit.
Additional Manufacturer Narrative
Qn#(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 338110.A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.The referenced lot number was manufactured and distributed prior to 2009 and has reached an expected end of life.The product complaint form references a nonrepairable determination by our service center and also notes a scratch on the jaws as the cause.This scratch did not occur in manufacturing or distribution which is evident by the more than 10 yrs of service history.

• Brand Name: HOR ENDO CLIP APPLIER MED-LG
• 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: 14619407
• Report Number: 3011137372-2022-00101
• Device Sequence Number: 4456156
• Product Code: GDO
• UDI-Device Identifier: 24026704710205
• UDI-Public: 24026704710205
• 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): 06/03/2022

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: IPN914987
• Device Catalogue Number: 338110
• Device Lot Number: 04A0900233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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