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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 Problems Leak/Splash (1354); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2019
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 felt something wrong when gripping the applier during the robot-assisted laparoscopic prostatectomy.Having checked the jaws, they were bent and misaligned.Another applier was used to continue the surgery and there was no injury to the patient.
 
Event Description
It was reported that the user felt something wrong when gripping the applier during the robot-assisted laparoscopic prostatectomy.Having checked the jaws, they were bent and misaligned.Another applier was used to continue the surgery and there was no injury to the patient.
 
Manufacturer Narrative
Qn#(b)(4).The dhr for the returned instrument has been 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)2018.The returned instrument was evaluated and found that the tube assembly is bent/damaged at the jaw end and the jaw pivot pin is pulled or pushed partially thru one side of the outer tube assembly and the jaws are loose and misaligned to each other in the closed position thus making this instrument unusable in its current condition thus we are able to validate the complaint.We are unable to determine what caused the outer tube assembly to be damaged at the jaw end but mishandling at the end user's facility is suspected.All instruments from this lot were 100% visually inspected and function tested prior to shipment to customer as this is a standardized procedure for this product line at this facility.
 
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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 Key8478675
MDR Text Key140789311
Report Number3011137372-2019-00091
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 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06A1863101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Date Manufacturer Received05/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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