BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT ACUTATE

    MDR report key: 3894282 · Received February 14, 2014

    Report

    Report Number
    2951238-2014-00056
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 28, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS NOT BEEN YET RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THE INSTRUCTION MANUAL WARNS: "IF THE ALARM TONE SOUNDS AND AN ERROR WINDOW IS DISPLAYED DURING THE PROCEDURE, IMMEDIATELY STOP THE PROCEDURE. DURING SURGICAL PROCEDURES, WITHDRAW THE TUNDERBEAT INSTRUMENT FROM THE BODY CAVITY. OTHERWISE, THE PROBE TIP MAY BREAK AND FALL OFF INSIDE THE BODY CAVITY."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, THE PROBE TIP ON THE THUNDERBEAT HANDPIECE BROKE OFF INSIDE THE PT. THE BROKEN TIP WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98501 OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT ACUTATE ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1