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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 08/02/2018
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 clip could not be loaded into the applier.There was no patient injury.
 
Event Description
It was reported that the clip could not be loaded into the applier.There was no patient injury.
 
Manufacturer Narrative
(b)(4).The dhr for the alleged instruments was evaluated and found to be completely without any irregularities.These instruments were produced at the (b)(4) as part of a 50pc.Lot in november of 2017.Instrument(s) have not been returned for evaluation therefore we are unable to validate the alleged complaint(s).All instruments produced at this facility are 100% visually inspected and function tested prior to shipping to customer as this is a standardized procedure for this facility.
 
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Brand Name
HOL ML 5 MILLIMETER ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7905658
MDR Text Key121589057
Report Number3011137372-2018-00267
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 company representative,foreig
Type of Report Initial,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06C1749074
Was Device Available for Evaluation? No
Date Manufacturer Received11/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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