MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM 45CM; APPLIER, SURGICAL, CLIP

Model Number	IPN915198
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the screw fell out of the handle while in surgery.
Additional Manufacturer Narrative
(b)(4).According to the supplier's investigation, the dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the manufacturing facility as part of a 50-pc.Lot in may 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 the manufacturing process.Evaluation of the returned instrument shows that the distal handle and shoulder screw are loose and separate from the instrument.There are no missing components from the returned instrument.We are able to validate this complaint.Evaluation of the shoulder screw and surrounding area on the proximal handle shows that this instrument was properly staked during its manufacture.Per ifu l02425 r01 which was included with this instrument at time of manufacture "as screws may become loose during normal operation of an instrument, inspect before and after use in order to ensure proper function." we are unable to determine what caused the screw to become loose but mishandling and lack of proper maintenance 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.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 the screw fell out of the handle while in surgery.

• Brand Name: HOL L ENDO APPLIER 10MM 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15620445
• Report Number: 3011137372-2022-00194
• Device Sequence Number: 6224721
• Product Code: GDO
• UDI-Device Identifier: 24026704697896
• UDI-Public: 24026704697896
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: IPN915198
• Device Catalogue Number: 544995L
• Device Lot Number: 06F1989689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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