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 Failure to Eject (4010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
Event Type  Injury  
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 when the physician was trying to seal the ureter the applier never opened; it required force to be removed along with a part of the ureter.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of a 50 pc.Lot in (b)(6) of 2017.The returned instrument was evaluated as received and found that the handle to jaw mechanism was sluggish/binding and knob rotation mechanisms was dry and sluggish feeling thus we are able to validate this complaint.After the initial evaluation this instrument was properly lubricated, and further evaluation showed that this instrument picks up, retains, closes and releases multiple clips as required of its function both with and without the use of silastic test tubing.Parts were 100% visually inspected and function tested at the (b)(4) before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.At this time, it is un-determined what caused the alleged issue, but it is suspected that the customer did not "lubricate" the instrument prior to sterilization as recommended in ifu (l06109 r04) supplied with the instrument which states "the instrument must be cleaned, lubricated, functionally checked, and sterilized prior to each use.Use a non-silicone, waterbased lubricant prior to sterilization.".
 
Event Description
It was reported that when the physician was trying to seal the ureter the applier never opened; it required force to be removed along with a part of the ureter.The patient's condition was reported as fine.
 
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 Key7689668
MDR Text Key114029624
Report Number3011137372-2018-00208
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 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06C1749070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Date Manufacturer Received08/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-