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

Catalog Number 544965

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

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 user found the jaw was deformed or bent during surgery.The user replaced the applier.There was no patient injury.

Manufacturer Narrative

Qn(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.Kenosha facility as part of a 50 pc.Lot in september of 2017.The returned instrument was evaluated and found that the tube assembly is damaged/bent open at the jaw end and the jaws are loose and misaligned and the drive rod is bent/damaged at the jaw end and the pivot pin has been pulled thru 1 side of the tube assembly thus we are able to validate this complaint.Parts were 100% visually inspected and tested 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 tube assembly to be damaged and for the drive rod to be bent at the jaw engagement area and for the jaws to be loose and misaligned and the jaw pivot pin to be pulled into the outer tube assembly but mishandling at end users facility is suspected.

Event Description

It was reported that the user found the jaw was deformed or bent during surgery.The user replaced the applier.There was no patient injury.

• 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: 7642581
• MDR Text Key: 112567389
• Report Number: 3011137372-2018-00187
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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: 06C1749044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1