BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LAT SERFAS ENERGY PROBE

    MDR report key: 1462043 · Received June 30, 2009

    Report

    Report Number
    2648666-2009-00127
    Event Type
    Malfunction
    Date Received
    June 30, 2009
    Date of Event
    June 6, 2009
    Report Date
    June 6, 2009
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS CUTTING A SOFT TISSUE (SLIGHTLY STRESSING ON THE INSTRUMENT) WHEN THE DISTAL PART OF THE ELECTRODE CAME OFF AND FELL DOWN THE SURGICAL SITE. THE SURGEON ATTEMPTED TO RETRIEVE IT WITH BASKET PLIERS AND SHATTERED THE DISTAL PART OF THE ELECTRODE. AFTER RETRIEVING THE PIECES, ANOTHER ITEM WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LAT SERFAS ENERGY PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 09091AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK