BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYBRID SURGICAL DEVICE (HSD) 10.5 CM CURVED

    MDR report key: 230109 · Received July 1, 1999

    Report

    Report Number
    1530517-1999-00001
    Event Type
    Other
    Date Received
    July 1, 1999
    Date of Event
    June 4, 1999
    Report Date
    July 1, 1999
    Manufacturer
    IHD, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING UVULO-PALATO-PHARYNGO-PLASTY) PROCEDURE. PHYSICIAN COMPLETED LEFT SIDE. WHILE MAKING A CUTTING PASS ON RIGHT SIDE, HE NOTED LOSS OF POWER. LASER TECH NOTED ENERGY STILL BEING PRODUCED AND TRANSMITTED, THEN RESET LASER. PHYSICIAN ATTEMPTED ANOTHER CUTTING PASS WITH NO TISSUE EFFECT. PHYSICIAN THEN NOTED BURNS TO LEFT AND RIGHT BUCCAL REGION OF PT'S MOUTH AND COMMISSURE REGION OF PT'S LIP. PROCEDURE WAS DISCONTINUED. PT'S BURNS WERE TREATED WITH BACTITRACIN. DEVICE WAS INSPECTED AND WRINKLES AND BUBBLES WERE NOTED ON SHAFT. TOTAL PROCEDURE TIME WAS 25 MINS. TOTAL LASER ENERGY USED WAS 4.4 KJ. DEVICE WAS RETURNED TO IHD AND EVALUATED. IT WAS DETERMINED FIBER TIP BURNED AND CEASED TO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRID SURGICAL DEVICE (HSD) 10.5 CM CURVED LASER DELIVERY AND ELECTROCAUTERY HANDPIECE GEI IHD, INC. NA 0000144

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other STATLASE SDL DIODE LASER.