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

Catalog Number 544965

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

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 jaws of the applier was found misaligned during use.Therefore, the user stopped to use it and replaced with a new one.The applier was purchased by the hospital within 1 year.

Event Description

It was reported that the jaws of the applier was found misaligned during use.Therefore, the user stopped to use it and replaced with a new one.The applier was purchased by the hospital within 1 year.

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).Lot in (b)(6)2019.Evaluation of the returned instrument shows that the diameter of the eye on one side of both jaws is undersized and one of the jaws is damaged at the tip.We are able to validate this complaint since we are unable to fully load a clip in the jaws of the returned instrument.We are unable to determine what caused the jaws to get damaged on this instrument but mishandling of the returned device at the end user's facility is suspected.All 50 instruments from this lot were 100% visually inspected and function tested prior to release to customer as this is a standardized procedure at this facility for this product line.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9873572
• MDR Text Key: 191039347
• Report Number: 3011137372-2020-00089
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06K1878150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1