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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP
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TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number 544965
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
Received from customer via medwatch form.No number assigned to form.During lap chole the surgeon attempted to use 5mm hem-o-locks but there was a malfunction of the clip applier.The surgeon applied a clip on the cystic duct and the applier could not be opened after the clip was deployed despite multiple attempts and manipulation of the instrument.A disposable metal clip applier was opened and the surgeon was able to fire three clips on the stump end of the cystic duct and additional up toward the gallbladder.The surgeon used scissors to cut out the clip that was stuck inside the applier.The gallbladder was removed from the abdomen and clips were inspected and looked to be intact.The patient tolerated the procedure well and there were no complications.Surgery was delayed approximately 20 minutes.
 
Manufacturer Narrative
(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 50 pc.Lot in july of 2018.Evaluation of the returned instrument shows that the jaws are aligned properly in the open and closed positions and there is no visible damage to the outer tube assembly area near the jaws.Functional testing shows that this instrument is able to pick-up, retain and close a clip but the clip remains stuck in the jaw after closure therefore we are able to validate this complaint.Further visual examination of the lower jaw (g00443 rev.06) using gage pins and microscope revealed that the jaw eyelet which grasps the clip is damaged / pushed in slightly on the 0.046 +/-.002 eyelet dimension causing it to be undersized and misshapen which is causing the clip tab to not slip out of the eyelet after the clip has been closed.We are unable to determine what caused the jaw eyelet to become damaged / pushed in slightly but mishandling of this device at the end user's facility is suspected.All 50 instruments from this 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.
 
Event Description
Received from customer via medwatch form.No number assigned to form.During lap chole the surgeon attempted to use 5mm hem-o-locks but there was a malfunction of the clip applier.The surgeon applied a clip on the cystic duct and the applier could not be opened after the clip was deployed despite multiple attempts and manipulation of the instrument.A disposable metal clip applier was opened and the surgeon was able to fire three clips on the stump end of the cystic duct and additional up toward the gallbladder.The surgeon used scissors to cut out the clip that was stuck inside the applier.The gallbladder was removed from the abdomen and clips were inspected and looked to be intact.The patient tolerated the procedure well and there were no complications.Surgery was delayed approximately 20 minutes.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10864433
MDR Text Key217147201
Report Number3011137372-2020-00246
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 other
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06A1863106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.
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