MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML ENDO APPLIER 5MM 45CM; APPLIER, SURGICAL, CLIP

Catalog Number	544965L
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that prior to use in the clinical setting, "brand new applier- first time use, would not hold clip since jaw is misaligned and pin seems to be the problem".No patient involvement.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states that prior to use in the clinical setting, "brand new applier- first time use, would not hold clip since jaw is misaligned and pin seems to be the problem".No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned to the manufacturer for investigation.The manufacturer, tecomet, reported "the dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.- kenosha wi, facility as part of a 25-pc.Lot in october of 2023.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 process.Evaluation of the returned instrument shows that the jaws are bent to the right and are loose and misaligned and the jaw pivot pin is pulled thru one side of the bent/damaged outer tube assembly.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod (n00185l) is bent/damaged, and its bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod to become bent and for its bosses to become damaged but mishandling of this device at the end user's facility is suspected.We are able to validate this complaint for the returned instrument.All 25 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 reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HOL ML ENDO APPLIER 5MM 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
• MDR Report Key: 18436307
• Report Number: 3011137372-2024-00004
• Device Sequence Number: 7781045
• Product Code: GDO
• UDI-Device Identifier: 34026704622499
• UDI-Public: 34026704622499
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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 Catalogue Number: 544965L
• Device Lot Number: 06C2359420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown