BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABLATOR-S 90 DEGREE

    MDR report key: 307066 · Received November 28, 2000

    Report

    Report Number
    2953127-2000-00019
    Event Type
    Other
    Date Received
    November 28, 2000
    Date of Event
    October 24, 2000
    Report Date
    November 27, 2000
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SHOULDER CASE USING A SUCTION ABLATOR, SMALL BURNS WERE CREATED AROUND THE PORTAL SITES WHERE THE PROBE HAD BEEN INSERTED. THE PHYSICIAN DID NOT USE A CANNULA. THE PHYSICIAN NOTICED THE FIRST BURN AT THE LATERAL PORTAL AFTER REMOVING THE PROBE. HE WENT TO INSERT THE PROBE IN THE ANTERIOR PORTAL AFTER FIRST CHECKING THE CONDITION OF THE SKIN. HE USED THE PROBE FOR ABOUT THREE TO FOUR MINUTES AND REMOVED IT FROM THE PT. AT THIS TIME HE NOTICED THE BURNS AROUND THE ANTERIOR PORTAL SITE AS WELL. THE BURNS BEEN DESCRIBED AS SUPERFICIAL, TYPE I, JUST REMOVING THE IMMEDIATE SKIN LAYER. THE PT'S SKIN TURNED WHITE BUT DID NOT BLEED. BOTH BURNS HAD CLEARED UP BY THE TIME OF THE F/U VISIT. THE BURNS WERE SO MINOR THE PT DID NOTICE THEM. NO CLINICAL SEQUELAE OR FURTHER COMPLICATIONS WERE REPORTED. THE PHYSICIAN DOES NOT FEEL THIS WAS A SIGNIFICANT EVENT AND ATTRIBUTES THE BURNS TO THE FACT THAT A CANNULA WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABLATOR-S 90 DEGREE ELECTROSURGICAL PROBE GEI ORATEC INTERVENTIONS, INC. NA 092200-19

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other