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

Catalog Number 544965

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2020

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 pivot pin of the applier was found stuck out when the user was going to use.The applier was sent to our technical specialist, who concluded it was unrepairable.

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.Kenosha wi facility as part of a (b)(4) pc.Lot in (b)(6)2019.Evaluation of the returned instrument shows that the jaw pivot pin is pushed thru one side of the outer tube assembly thus we are able to validate this complaint.We are unable to determine what caused the jaw pivot pin to be pushed into one side of the outer tube assembly but mishandling of this device at the end user's facility is suspected.All (b)(4) instruments from this lot were (b)(4) visually inspected and function tested prior to release to customer as this is a standardized procedure at this facility for this product line.

Event Description

It was reported that the pivot pin of the applier was found stuck out when the user was going to use.The applier was sent to our technical specialist, who concluded it was unrepairable.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10066294
• MDR Text Key: 191422286
• Report Number: 3011137372-2020-00111
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: 06F1871320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1