BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 VIDEO GUIDED CATHETER

    MDR report key: 6490020 · Received April 13, 2017

    Report

    Report Number
    1062474-2017-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    April 13, 2015
    Report Date
    August 7, 2015
    Manufacturer
    MYELOTEC, INC
    Product Code
    HRX
    PMA / PMN Number
    K980734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER HAS A VERY SHARP BEND IN THE SOFT TIP CAUSED BY OVER-STEERING. THIS CAN ONLY HAPPEN WITH NO FIBEROPTIC SCOPE IN POSITION AND BY TURNING THE STEERING DIAL AS FAR AS IT WILL GO. WE HAVE A STEERING STOP INSIDE THE HANDLE, BUT IT IS INTENDED FOR USE IN CONJUNCTION WITH A SCOPE TO PREVENT THIS TYPE OF DAMAGE.

    Description of Event or Problem · 1

    SHAFT BENDING CONTROL ERROR. WHILE IN IT USE, SHAFT BENDING WAS NOT RELEASED. FIBER AND SCOPE COULD NOT GET IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271338 2010 VIDEO GUIDED CATHETER CATHETER WITH ENDOSCOPE HRX MYELOTEC, INC 4250/MY06614

    Patients

    Seq Age Sex Outcome Treatment
    1