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 11/27/2018

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 jaws of the applier got bent while in use on a patient.

Event Description

It was reported that the jaws of the applier got bent while in use on a patient.

Manufacturer Narrative

Qn# (b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.(b)(4) facility as part of a (b)(4) pc.Lot in july of 2015.The returned instrument was evaluated and found that the tube assembly is bent/damaged at the jaw end and the drive rod is bent/damaged where it engages the jaws and the jaws are loose and misaligned.As received , this instrument is complete and is not missing any of its components.This instrument is unusable in its current condition therefore we are able to validate this complaint.All instruments are 100% visually inspected and function tested prior to shipment to customer as this is a standardized procedure for this product line at this facility.We are unable to determine what caused the tube assembly to be damaged at the jaw end and for the tube assembly and the drive rod to be bent/damaged but mishandling of this device at the end users facility is suspected.

• 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: 8107221
• MDR Text Key: 128597164
• Report Number: 3011137372-2018-00319
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• 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: 06B1514051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1