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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 Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 07/06/2020
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
Reported issue: the horizon medium clips tend to stick on the side of the horizon medium 8" open applier after ligating.This is prone to damage to a blood vessel such as vessel tear if user not aware while removing the applier after application.Cabg cardiac case.
 
Event Description
Reported issue: the horizon medium clips tend to stick on the side of the horizon medium 8" open applier after ligating.This is prone to damage to a blood vessel such as vessel tear if user not aware while removing the applier after application.Cabg cardiac case.
 
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) piece lot in august of 2018.Evaluation of the returned instrument shows that the light blue color coding on both rings is slightly faded.Further evaluation shows that there is a small nick on the inner jaw slot of one of the jaws.Functional evaluation using silastic test tubing shows that this instrument is able to pick-up, retain, close and release a clip without clip sticking to inner jaw surface thus we are unable to validate the alleged complaint since we were unable to replicate the alleged issue.We are unable to determine what caused the nick on the inner jaw slot of one of the jaws but mishandling at the end user's facility is suspected.All (b)(4) 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 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 Key10573515
MDR Text Key208142861
Report Number3011137372-2020-00200
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 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number237081
Device Lot Number06J1756414
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Date Manufacturer Received10/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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