BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SONICBET 5M, 35CM, PISTOL GRIP

    MDR report key: 4180761 · Received October 15, 2014

    Report

    Report Number
    2951238-2014-00450
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT TOWARDS THE END OF A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE PROBE BROKE OFF AND FELL INSIDE THE PATIENT. THE BROKEN PROBE WAS RETRIEVED FROM THE PATIENT'S ABDOMEN USING AN UNIDENTIFIED GRASPER DEVICE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654774 OLYMPUS SONICBET 5M, 35CM, PISTOL GRIP SONICBEAT GEI OLYMPUS MEDICAL SYSTEM CORPORATION SB-0535PC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1