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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
Model Number IPN915189
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2022
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is completed.Teleflex will continue to monitor and trend related events.(the device investigation may be found in associated report 3011137372-2023-00012).
 
Event Description
Reported event: the jaws of the applier were found bent before use.Therefore, a new unit was used instead.The applier was sent to our technical specialist, who confirmed the jaws were broken and the screw of the handle were loose.
 
Manufacturer Narrative
(b)(4).The device history record (dhr) review for the returned instrument was completed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a (b)(4)-pc.Lot in july of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument shows that the jaws are loose and misaligned and bent to the right and the jaw pivot pin is pulled thru one side of the bent/ damaged outer tube assembly.It was also found that the shoulder screw that holds the handles together was slightly loose but not fully unscrewed from the proximal handle assembly.We are able to validate this complaint.After the initial evaluation the screw was tightened down properly, and it was noted that this instrument was properly staked in 3 places during its production.We are unable to determine what caused the jaws to be loose and misaligned and bent to the right and the jaw pivot pin is pulled thru one side of the bent/damaged outer tube assembly and for the shoulder screw to be slightly backed out of the proximal handle assembly but mishandling and lack of proper maintenance of this device at the end user's facility is suspected.All (b)(4) 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.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Reported event: the jaws of the applier were found bent before use.Therefore, a new unit was used instead.The applier was sent to our technical specialist, who confirmed the jaws were broken and the screw of the handle were loose.
 
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Brand Name
HOL ML 5MM ENDO APPLIER
Type of Device
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
marling heaton
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key16329515
MDR Text Key309134041
Report Number3011137372-2023-00021
Device Sequence Number1
Product Code GDO
UDI-Device Identifier24026704696813
UDI-Public24026704696813
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 01/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN915189
Device Catalogue Number544965
Device Lot Number06E2002049
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/24/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
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