BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 806776 · Received January 15, 2007

    Report

    Report Number
    2648666-2007-00003
    Event Type
    Injury
    Date Received
    January 15, 2007
    Date of Event
    December 20, 2006
    Report Date
    December 20, 2006
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, AN ABLATION SCREEN SEPARATED FROM THE CERAMIC PROBE HEAD. THE SCREEN WAS LOST IN THE KNEE JOINT AND UPON SEEING THE CERAMIC HEAD WITHOUT THE SCREEN, THE REP STATED THIS TO THE PHYSICIAN. THE PHYSICIAN ASKED IF IT WAS METAL, THE REP REPORTED YES. THE SURGEON WENT ON WITH THE PROCEDURE AND AT THE END BROUGHT IN AN X-RAY MACHINE TO TAKE BOTH AP AND LATERAL FILMS. THE SCREEN WAS FOUND IN THE RIGHT KNEE, POSTERIOR LATERAL GUTTER. THE SURGEON THEN RETRIEVED IT WITH A GRASPER THROUGH AN EXTRA LATERAL INCISION. IT WAS CONFIRMED THAT THE PIECE WAS RETRIEVED WITH ANOTHER X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90-S SERFAS ENERGY SUCTION PROBE RF ABLATION PROBE GEI STRYKER ENDOSCOPY PUERTO RICO * 06325AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention