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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HZ APPLIER MED 8" CVD; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 237081
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2020
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 clip was not easily detached from the applier after ligation during a pretest.The applier was sent to our technical specialist, who determined it was unrepairable.It was purchased by the hospital in (b)(6) 2019.
 
Event Description
It was reported that the clip was not easily detached from the applier after ligation during a pretest.The applier was sent to our technical specialist, who determined it was unrepairable.It was purchased by the hospital in (b)(6)2019.
 
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).Lot in (b)(6)2018.Evaluation of the returned instrument shows that the open tip gap is undersized to teleflex print specifications of.157 +/-.005 at.099.Evaluation of this instrument shows that it is unable to load a clip from a cartridge in its current state.Further evaluations show that the tips are misaligned in the closed position and the spring bend has been altered from its original shape near the spring clasp on the single side of the applier which would decrease open tip gap thus we are able to validate this complaint.We are unable to determine what caused the tips to be misaligned in the closed position and for this applier open jaw gap to be undersized but mishandling at the end user's facility is suspected.All 100 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
HZ APPLIER MED 8" CVD
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10014564
MDR Text Key189570722
Report Number3011137372-2020-00105
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 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number237081
Device Lot Number06J1756436
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2020
Initial Date Manufacturer Received 04/06/2020
Initial Date FDA Received04/30/2020
Supplement Dates Manufacturer Received06/04/2020
Supplement Dates FDA Received06/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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