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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 Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2019
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 the user was unable to ligate after a cracking sound from the applier during use.The device was checked and found that the tip of jaws was misaligned.It was replaced with a new applier.No clips fell in the patient.
 
Event Description
It was reported that the user was unable to ligate after a cracking sound from the applier during use.The device was checked and found that the tip of jaws was misaligned.It was replaced with a new applier.No clips fell in the patient.
 
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 facility as part of a 50 pc.Lot in (b)(6) of 2018.The returned instrument was evaluated and found that the outer tube assembly is bent/flared open at the jaw end and the jaws are loose and misaligned and the jaw pivot pin is pushed thru one side of the outer tube assembly therefore we can validate this complaint.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to release to the customer as this is a standardized procedure at this facility for this product line.We are unable to determine what caused the outer tube assembly to be bent/flared open at the jaw end and the jaws to be loose and misaligned and the jaw pivot pin to be pushed thru one side of the outer tube assembly but mishandling of this device at the end user's facility is suspected.
 
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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 Key8707444
MDR Text Key148285635
Report Number3011137372-2019-00169
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 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06A1863100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Date Manufacturer Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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