BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3830003 · Received March 13, 2014

    Report

    Report Number
    2951238-2014-00093
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS NOT YET BEEN 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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A PROCEDURE, THE PHYSICIAN USED THE HANDPIECE WHEN HE NOTICED THAT A BLUE PLASTIC MATERIAL (SHEATH PROTECTIVE COVER) APPEARED ON THE JAW AND ON THE FALLOPIAN TUBE OF THE PT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND WITHOUT INCIDENT. NO PT INJURY WAS REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO AND WAS INFORMED THAT THE PROCEDURE WAS A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY. DURING THE PROCEDURE, THE BLUE PLASTIC MATERIAL FELL OUT OF THE DEVICE AND FELL INTO THE PT'S UTERUS. THE BROKEN PIECE WAS RETRIEVED. THE SOURCE OF THE BROKEN PIECE APPEARED TO BE PART OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151087 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP THUNDERBEAT FRONT-ACTUATED GRIP GEI OLYMPUS MEDICAL SYSTEM CORP TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1