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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM 45CM
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TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM 45CM Back to Search Results
Catalog Number 544995L
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
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 only with strength and pressure can a clip be taken out of the box with the applier.However, the box is damaged and plastic residues stick on the applier.Additional information indicates that the applier was bent at the front.There was no patient injury.
 
Event Description
It was reported that only with strength and pressure can a clip be taken out of the box with the applier.However, the box is damaged and plastic residues stick on the applier.Additional information indicates that the applier was bent at the front.There was no patient injury.
 
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 25 pc.Lot in (b)(6)2017.The returned instrument was evaluated and found that the open jaw gap is undersized and the knob and tube assembly with the luer flush port and cap is rotated 180 degrees from its original placement on tube assembly thus decreasing the original jaw gap as set at time of production making it difficult to pick up a clip from the cartridge thus we are able to validate the alleged complaint.After initial evaluation of the returned instrument the luer flush port was removed and the knob was rotated back 180 degrees and the flush port was re-installed and the open jaw gap was remeasured at.365 which is to print specifications of.385 +/-.025.Further evaluation showed that after returning the instrument to its original configuration that this instrument is able to pick up, retain , close and release multiple clips with and without the use of silastic test tubing.Mishandling/tampering of the returned device at the end users facility is suspected.
 
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Brand Name
HOL L ENDO APPLIER 10MM 45CM
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8826807
MDR Text Key152520098
Report Number3011137372-2019-00240
Device Sequence Number1
Product Code FZP
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 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544995L
Device Lot NumberUNKN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2019
Date Manufacturer Received09/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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