MAUDE Adverse Event Report: TELEFLEX MEDICAL HOR ENDO APPLIER, M/L, 45CM; APPLIER, SURGICAL, CLIP

Model Number	IPN914989
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
It was reported that "applicator is not holding the clips, unable to hold the clip".
Additional Manufacturer Narrative
(b)(4).Per customer provided information the dhr for the alleged defective instrument was reviewed and found completely without any irregularities.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All 10 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
It was reported that "applicator is not holding the clips, unable to hold the clip".
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer.The manufacturer, tecomet, reported: "the dhr for the returned instrument was reviewed and found complete without any irregularities.The alleged instrument was produced by aesculap, inc.Kenosha wi facility as part of a 10 pc lot in april of 2020.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing processes.Evaluation of the returned device shows that one of the jaws is bent/damaged.We are able to validate this complaint for the returned instrument since in its current state it will not pick up a clip from the cartridge.We are unable to determine what caused one of the jaws to become bent damaged and misaligned to the other jaw but mishandling of this device at the end user's facility is suspected.All 10 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." teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "applicator is not holding the clips, unable to hold the clip".

• Brand Name: HOR ENDO APPLIER, M/L, 45CM
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15477340
• Report Number: 3011137372-2022-00187
• Device Sequence Number: 12279673
• Product Code: GDO
• UDI-Device Identifier: 24026704710212
• UDI-Public: 24026704710212
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 08/29/2022

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: IPN914989
• Device Catalogue Number: 338170
• Device Lot Number: 06A2097694
• 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: 08/29/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 03/18/2024
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 11/07/2022; 03/18/2024
• 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.; N/A.
• Patient Sex: Unknown