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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 Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (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 jaws of the applier were misaligned so that it failed to ligate during a laparoscopic cholecystectomy.The operation managed to be completed and nothing fell/remained in the patient visually.However, the pivot pin was found loose so that the user would like us to inspect if there are any parts missing in the applier.The applier was purchased by the hospital on (b)(4) 2019.
 
Event Description
It was reported that the jaws of the applier were misaligned so that it failed to ligate during a laparoscopic cholecystectomy.The operation managed to be completed and nothing fell/remained in the patient visually.However, the pivot pin was found loose so that the user would like us to inspect if there are any parts missing in the applier.The applier was purchased by the hospital on (b)(6) 2019.
 
Manufacturer Narrative
(b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a (b)(4).Lot in may of 2019.Evaluation of the returned instrument shows that it is completely, and the only missing component is its luer flush port cap.Further evaluation shows that the jaws are slightly loose and misaligned, and the jaw pivot pin is slightly sticking out on one side of the outer tube assembly therefore we are able to validate this complaint.This instrument was disassembled for further evaluation of internal components and it was found that both of the drive rod (n00185) fingers that activate the jaws were also damaged.We are unable to determine how the jaws became slightly misaligned and loose and for the jaw pivot pin to be slightly sticking out on one side of the outer tube assembly but it is suspected that mishandling of this device at the end user's facility caused the drive rod (n001 85) fingers to become damaged and that in turn caused the jaws to become slightly loose and misaligned and for the jaw pivot pin to be slightly sticking out of the outer tube assembly.All 50 instruments from the 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.
 
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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 Key10906621
MDR Text Key218732197
Report Number3011137372-2020-00250
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 foreign,health professional
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06F1871331
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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