BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPE CABLE EXERA II

    MDR report key: 3830019 · Received March 13, 2014

    Report

    Report Number
    2951238-2014-00107
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    OLYMPUS MED SYS CORP
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL WAS UNABLE TO DUPLICATE THE REPORTED PHENOMENON. THE VIDEO SCOPE CABLE WAS CONNECTED TO THE OLYMPUS TEST EQUIPMENT AND NO SHOCK WAS FELT WHILE HOLDING IT DURING THE INVESTIGATION. IN ADDITION, BOTH CONNECTORS WERE DISASSEMBLED BUT FOUND NO CORROSION AND ALL WIRINGS AND PARTS WERE GROUNDED CORRECTLY. EVIDENCE OF FLUID INVASION WAS NOTED BENEATH THE SERIAL NUMBER PLATE AND FACTORY NUMBER. SCRATCH MARKS ON THE ROUND CONNECTOR AND BLACK STAINS ON THE CONTACT PINS WERE ALSO NOTED. THE DEVICE PASSED THE CONTINUITY TEST. THE DEVICE WAS RETURNED UNREPAIRED PER CUSTOMER'S REQUEST. PER INSTRUCTION MANUAL "IF THE DEVICE IS USED WHILE STILL WET, THERE IS THE RISK OF AN ELECTRIC SHOCK."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE NURSE RECEIVED A MILD ELECTRICAL SHOCK WHEN ATTACHING THE VIDEO CABLE TO THE ENDOSCOPE. NO OTHER INFO WAS PROVIDED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO AND WAS INFORMED THAT THE EVENT OCCURRED DURING THE SET UP PROCESS OF A COLONOSCOPY. THE GI TECH FELT THE ELECTRICAL SHOCK FROM THE HAND TO THE ELBOW. THERE WAS NO PT INVOLVEMENT. NO MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151285 SCOPE CABLE EXERA II SCOPE CABLE FDF OLYMPUS MED SYS CORP MAJ-1430 NA

    Patients

    Seq Age Sex Outcome Treatment
    1