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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2020
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 jaws of the applier did not open enough to load a clip properly during a surgery.Therefore, a new unit was used instead.It was the first use of the applier after purchasing it on (b)(6) 2020.
 
Event Description
It was reported that the jaws of the applier did not open enough to load a clip properly during a surgery.Therefore, a new unit was used instead.It was the first use of the applier after purchasing it on may 2020.
 
Manufacturer Narrative
(b)(4).Per customer provided information the dhr for the alleged instrument was reviewed and found completely without any irregularities.The alleged instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 50 pc.Lot in august of 2019.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All 50 instruments from the alleged lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for the 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 Key10179474
MDR Text Key195954566
Report Number3011137372-2020-00145
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 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06C1985918
Was Device Available for Evaluation? No
Date Manufacturer Received08/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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