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

Catalog Number 544965

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the applier got bent at the distal area while in use.There are no reports regarding clips falling in the patient.

Manufacturer Narrative

Qn#(b)(4).The dhr for the alleged instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc kenosha, wi facility as part of a 45 pc.Lot in november of 2017.The returned instrument was evaluated and found that the luer port cap is missing and the tube assembly is bent/damaged at the jaw end and the jaw pivot pin is pulled thru one side of the tube assembly and the jaws are loose and misaligned and the drive rod is bent/damaged where it activates the jaws thus we are able to validate the alleged complaint.We are unable to determine what caused the tube assembly and the drive rod to be bent/damaged and for the pivot pin to be pulled/pushed thru one side of the tube assembly and for the jaws to be misaligned but mishandling at the end users facility is suspected.All instruments from this lot were 100% visually inspected and function tested prior to shipment to customer as this is a standardized procedure at this facility for this product line.

Event Description

It was reported that the applier got bent at the distal area while in use.There are no reports regarding clips falling in the patient.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8433566
• MDR Text Key: 139232096
• Report Number: 3011137372-2019-00075
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06C1749064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1