BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULTRASONIC GENERATOR

    MDR report key: 4092059 · Received August 21, 2014

    Report

    Report Number
    2951238-2014-00320
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 5, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE WHILE USING A THUNDERBEAT DEVICE, THE ULTRASONIC GENERATOR DISPLAYED SEVERAL ERROR MESSAGES. ONE ERROR MESSAGE STATED "ESU NEEDS TO RESTART." BOTH OF THE GENERATOR DEVICES WERE POWERED OFF AND ON BUT THE SAME ERROR MESSAGE WAS OBSERVED. BOTH GENERATOR DEVICES WERE REPLACED. WHILE THE STAFF WAS OBTAINING ANOTHER THUNDERBEAT DEVICE, THE PT STARTED TO BLEED EXCESSIVELY, AND REQUIRED AN IMMEDIATE OPEN SURGICAL PROCEDURE TO CONTROL THE BLEEDING. THE PT'S CURRENT CONDITION IS CRITICAL BUT NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILS REGARDING THE REPORTED EVENT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504535 SULTRASONIC GENERATOR GENERATOR GEI OLYMPUS WINTER & IBE GMBH USG-400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SERIAL #: (B)(4)| MFR REPORT 2951238-2014-00385: MODEL - THUNDERBEAT| MFR REPORT 2951238-2014-00319: MODEL ESG-400,| SERIAL # UNK