MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL APPLIER XL 11" RA; APPLIER, SURGICAL, CLIP

Catalog Number	544192
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " jaws not holding the clips properly, clips fall out".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The sample was not returned to the manufacturer for evaluation.The manufacturer reported: "per customer provided information the ohr for the alleged defective medical device was reviewed and found complete without any irregularities.The alleged defective instrument was produced at the tecomet, inc.(b)(6), wi facility as part of a (b)(4) pc.Lot in (b)(6) 2022.It was found that this order was made from the correct materials and components and all approved processes were followed.This instrument has not been returned for review or evaluation and the customer provided picture shows someone holding an applier and one side of the clip is not securely locked into the eyelets of one of the jaws.We are unable to determine what is causing the alleged issue with this applier with the customer supplied photo or validate this complaint.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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " jaws not holding the clips properly, clips fall out".No patient involvement reported.

• Brand Name: HOL APPLIER XL 11" RA
• 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: 19721108
• Report Number: 3011137372-2024-00094
• Device Sequence Number: 8290308
• Product Code: GDO
• UDI-Device Identifier: 34026704623601
• UDI-Public: (01)34026704623601(11)220225(17)001231(10)06F2137541(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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
• Device Catalogue Number: 544192
• Device Lot Number: 06F2137541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown