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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP
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HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544965
Device Problems Leak/Splash (1354); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
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 applier is misaligned and during surgery is not closing property, the clips are falling.
 
Event Description
It was reported that the applier is misaligned and during surgery is not closing property, the clips are falling.
 
Manufacturer Narrative
(b)(4).Per information provided from customer the dhr for the alleged device was reviewed and found completely without any irregularities.This instrument was produced as part of a 50 pc.Lot in november of 2017.This instrument has not been returned for review or evaluation therefore we are unable to determine what might have caused the jaws to be misaligned and also unable to validate the alleged complaint.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
MDR Report Key9165879
MDR Text Key166390287
Report Number3011137372-2019-00363
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,u
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06C1749066
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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