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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER SMALL 8" CVD; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HZ APPLIER SMALL 8" CVD; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 137081
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2020
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 a clip was not easily detached from the applier after ligation during pretest.The applier was sent to our technical specialist, who determined it was unrepairable.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) pc.Lot in (b)(6)2018.Evaluation of the returned instrument shows that the tips are aligned in the open and closed position.Further evaluation shows that this instrument is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing.We are unable to replicate the alleged issue therefore we are unable to validate this complaint.All (b)(4) 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.
 
Event Description
It was reported that a clip was not easily detached from the applier after ligation during pretest.The applier was sent to our technical specialist, who determined it was unrepairable.The applier was purchased by the hospital within 1 year.
 
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Brand Name
HZ APPLIER SMALL 8" CVD
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9694095
MDR Text Key191034764
Report Number3011137372-2020-00059
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 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number137081
Device Lot Number06C1747933
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Date Manufacturer Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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