BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPULSE POWERSUITE

    MDR report key: 6325235 · Received February 13, 2017

    Report

    Report Number
    6325235
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 1, 2017
    Manufacturer
    LUMENIS, INC. SLC (COHERENT MEDICAL INC.)
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOLMIUM LASER BROUGHT INTO O.R., PLUGGED INTO WALL SOCKET, AND THEN TURNED ON. THE POWER WAS NOT ON AND CALLED CHARGE NURSE. WHEN SURGEON WAS READY FOR THE LASER, POWER WAS STILL NOT ON, FACILITIES WAS CALLED AND THEY SAID POWER WAS ON. THE LASER WAS TAKEN TO ANOTHER ROOM FOR TESTING AND FACILITIES CAME TO O.R. TO TEST AND REPAIR THE WALL SOCKET. THE WALL SOCKET WAS REPAIRED BY FACILITIES. THE LASER WAS TURNED ON AND A FIBER WAS ATTACHED, THEN THE LASER WOULD NOT GO TO READY STATUS, THE LASER REMAINED ON STANDBY STATUS. AT THAT TIME, A NEW LASER WAS BROUGHT TO O.R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109472 VERSAPULSE POWERSUITE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS, INC. SLC (COHERENT MEDICAL INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR