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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
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.
 
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Brand Name
HOL ML 5 MILLIMETER ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9873572
MDR Text Key191039347
Report Number3011137372-2020-00089
Device Sequence Number1
Product Code GDO
Combination Product (y/n)N
Number of Events Reported1
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 Number544965
Device Lot Number06K1878150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Initial Date Manufacturer Received 03/06/2020
Initial Date FDA Received03/24/2020
Supplement Dates Manufacturer Received04/13/2020
Supplement Dates FDA Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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