BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25GA/0.5 MM STEPPED ILLUMINATING LASER PROBE

    MDR report key: 7206541 · Received January 19, 2018

    Report

    Report Number
    2529392-2018-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    January 15, 2018
    Report Date
    January 19, 2018
    Manufacturer
    PEREGRINE SURGICAL, LTD.
    Product Code
    HQB
    PMA / PMN Number
    K132614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 25GA CURVED ILLUMINATING LASER PROBE STOPPED WORKING DURING CASE RESULTING IN SURGICAL TREATMENT DELAY. MANUFACTURER WILL WORK WITH CURRENT INVENTORY (UNUSED SAMPLES) TO TRY TO RECREATE FAILURE TO DETERMINE CAUSE.

    Description of Event or Problem · 1

    DURING A SURGICAL CASE A 25GA CURVED ILLUMINATING LASER PROBE (7625.ALCU LOT # 739402) WAS BEING USED WITH THE FOLLOWING PARAMETERS, 250,200,50. AFTER A MINUTE OF LASER USED AN AUDIBLE "POP" SOUND WAS HEARD, THE LASER STOPPED WORKING, AND SMOKE WAS OBSERVED EMANATING FROM THE TIP TWO OTHER PROBES FROM THE SAME LOT WERE TRIED WITH THE SAME RESULT. THE CASE WAS HALTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50087 25GA/0.5 MM STEPPED ILLUMINATING LASER PROBE 25GA CURVED ILLUMINATING LASER PROBE HQB PEREGRINE SURGICAL, LTD. 7625.ALCU 739402

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other