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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 Failure to Align (2522); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2019
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 was unable to lock a clip during a robot-assisted laparoscopic prostatectomy.It was replaced with a new one to complete the surgery.No clips fell in the patient and there was no injury to the patient.After the surgery, the user checked the applier and found that the jaws were misaligned.No touch or response was felt when gripping the handle.
 
Manufacturer Narrative
Qn#(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 june of 2018.The returned instrument was evaluated and found that the jaw picot pin is slightly pushed thru the outer tube assembly and the jaws are loose and misaligned thus we are able to validate this complaint.Further evaluation showed that the chamfer diameter on the exposed side of the tube assembly(j44369) where the pivot pin was pulled partially thru was measured using a vision system and it measured at 0.074 which is to teleflex print specifications of 0.078 +.002/-.006.We are unable to determine what caused the jaw pivot pin to be partially pulled thru the outer tube assembly 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 customer as this is a standardized procedure at this facility for this product line.
 
Event Description
It was reported that the user was unable to lock a clip during a robot-assisted laparoscopic prostatectomy.It was replaced with a new one to complete the surgery.No clips fell in the patient and there was no injury to the patient.After the surgery, the user checked the applier and found that the jaws were misaligned.No touch or response was felt when gripping the handle.
 
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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 Key8433434
MDR Text Key139232465
Report Number3011137372-2019-00081
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 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544965
Device Lot Number06A1863100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Date Manufacturer Received04/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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