BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESCOPE TITANIUM SMART CABLE

    MDR report key: 5635352 · Received May 5, 2016

    Report

    Report Number
    9615393-2016-00306
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    October 28, 2015
    Report Date
    November 11, 2015
    Manufacturer
    VERATHON MEDICAL ULC
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS RECEIVED FOR EVALUATION AND THE REPORTED FAILURE COULD NOT BE DUPLICATED. TECH SERVICES KEPT THE CABLE CONNECTED TO A TEST BATON UNTIL MONITOR AUTOMATICALLY SHUT OFF. THE PROBLEM COULD NOT BE CONFIRMED. ADDITIONAL PART USED: TITANIUM SU LOPRO S3; CATALOG: 0270-0769; LN: 020515. THIS MDR IS BEING FILED AS RESULT OF A RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE TITANIUM SMART CABLE, AFTER A COUPLE OF MINUTES THE IMAGE STARTED TO JUMP. A DELAY IN THE PROCEDURE OF UNKNOWN DURATION OCCURRED AS ANOTHER SMART CABLE WAS OBTAINED. NO HARM TO PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289562 GLIDESCOPE TITANIUM SMART CABLE LARYNGOSCOPE, RIGID CCW VERATHON MEDICAL ULC 0800-0531

    Patients

    Seq Age Sex Outcome Treatment
    1