Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544965
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/23/2018
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 during laparoscopic cholecystectomy, the user loaded a clip into the jaws as usual manner, and no irregular issue occurred at that time.When ligating the vessel with the clip, the user felt something abnormal with the applier.When the applier was removed the jaws were bent.There was no patient injury.
 
Event Description
It was reported that during laparoscopic cholecystectomy, the user loaded a clip into the jaws as usual manner, and no irregular issue occurred at that time.When ligating the vessel with the clip, the user felt something abnormal with the applier.When the applier was removed the jaws were bent.There was no patient injury.
 
Manufacturer Narrative
(b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This device was produced at the (b)(4) as part of a 50pc.Lot in (b)(6) of 2017.Evaluation of the returned instrument shows that the tube assembly is bent open/damaged at the jaw end and the drive rod is bent/damaged where it engages the jaws and the jaws are loose and misaligned and the pivot pin is pulled thru one side of the tube assembly signifying that this instrument is unusable in its current state thus we are able to validate the alleged complaint.All instruments produced at this facility are 100% visually inspect and function tested prior to shipment to customer as this is a standardized process at this facility.We are unable to determine what caused the tube assy.To be damaged at the jaw end but mishandling of this device at the end users facility is suspected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8051193
MDR Text Key126654523
Report Number3011137372-2018-00304
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 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2023
Device Catalogue Number544965
Device Lot Number06C1749059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-