MAUDE Adverse Event Report: TELEFLEX MEDICAL; APPLIER, SURGICAL, CLIP

Catalog Number 544965

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the applier was bent and the jaws were impossible to use.There was no reported patient injury.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.(b)(4) facility as part of a 50 pc.Lot in january of 2017.Evaluation of the returned instrument shows that the jaws are loose and misaligned to each other and the jaw pivot pin has been popped thru one side of the tube assembly and one side of the tube assembly is bent/damaged outward and the end of the drive rod that activates the jaws is also bent/damaged thus we are able to validate this complaint.Parts were 100% function tested and visually inspected at the tecomet, inc.Kenosha facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.At this time it is un-determined what caused the jaws to be loose/misaligned and the pivot pin to be pulled thru one side of the tube assembly and the drive rod and tube assembly to be bent/damaged at the jaw end but mishandling at end users facility is suspected.

Event Description

It was reported that the applier was bent and the jaws were impossible to use.There was no reported patient injury.

• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7578236
• MDR Text Key: 110363151
• Report Number: 3011137372-2018-00140
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: 06G1637506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1