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

Catalog Number	544995
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the rotation knob of the applier did not turn smoothly so that the jaws sometimes kept closed during a surgery.Therefore, the applier was replaced with a new one to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred.Our sales rep.Checked the applier and found that the jaws were slightly misaligned".The patient status is reported as "fine".
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.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4) pc.Lot in july of 2022.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 slightly loose and misaligned to each other in the closed position and as received it has a non-teleflex type luer flush port cap installed on it.Functional testing shows that the handle to jaw and knob rotation mechanisms are sluggish and binding in multiple positions when they are actuated.We are able to validate this complaint for the returned instrument.After the initial evaluation this instrument was dis-assembled and cut-up in order to evaluate its internal components to determine a root cause for the sluggish and binding mechanisms.It was found that the stem of the proximal handle and the top portion of the drive rod shaft are bent/damaged thus creating the sluggish /binding feel when the mechanisms are actuated in multiple positions.We are unable to determine what caused the jaws to be slightly misaligned in the closed position and for the top portion of the drive rod and stem portion of the proximal handle to become bent/damaged but mishandling of this device at the end user's facility is suspected.All (b)(4) 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 "the rotation knob of the applier did not turn smoothly so that the jaws sometimes kept closed during a surgery.Therefore, the applier was replaced with a new one to complete the procedure.No clip fell/remained in the patient and no injury to the patient occurred.Our sales rep.Checked the applier and found that the jaws were slightly misaligned".The patient status is reported as "fine".

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18544610
• Report Number: 3011137372-2024-00018
• Device Sequence Number: 20813946
• Product Code: GDO
• UDI-Device Identifier: 34026704623649
• UDI-Public: 34026704623649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: 544995
• Device Lot Number: 06A2244781
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown