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

Model Number	IPN915197
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
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 clips got broken during a surgery.It was unknown whether the issue occurred at loading or at ligation.Therefore, the applier was replaced with another one.No clip fell/remained in the patient.The sales representative checked the applier and confirmed that the opening of the jaws was slightly narrow.The applier was purchased by the hospital on (b)(6) 2021.
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 50-piece lot in (b)(6) of 2019.Evaluation of the returned instrument shows that there is no visible damage to the inner jaw slot or eyelets of the jaws.Further evaluation shows that the jaw (g00416/g00417) slot widths print dimension of.060 +/-.003" are to teleflex print specifications at.060" and the open and closed tip set gaps are also to teleflex print specifications of.004/.012" at.008" for the closed jaw gap and the open jaw gap specification of.385+/-.025" measures at.380".Functional testing of this device as performed at time of manufacture shows that it is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing without breaking any clips in the process.We are unable to determine what caused the alleged issue at the end user's facility since we were unable to find any non-conforming features on the returned device or replicate the alleged issue.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.
Event or Problem Description
The clips got broken during a surgery.It was unknown whether the issue occurred at loading or at ligation.Therefore, the applier was replaced with another one.No clip fell/remained in the patient.The sales representative checked the applier and confirmed that the opening of the jaws was slightly narrow.The applier was purchased by the hospital on (b)(6) 2021.

• 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: 12737838
• Report Number: 3011137372-2021-00305
• Device Sequence Number: 17168559
• 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): 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN915197
• Device Catalogue Number: 544995
• Device Lot Number: 06C1985960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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
• Patient Sex: Unknown