BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 20CM INLINE GRIP

    MDR report key: 4173519 · Received October 10, 2014

    Report

    Report Number
    2951238-2014-00397
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 17, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF AN EXPLORATORY LAPAROTOMY, AS WELL AS MULTIPLE OTHER PROCEDURES, THE TIP OF THE PROBE BROKE OFF. THE PATIENT ALSO HAD AN ESTIMATED BLOOD LOSS OF 1500 ML, HOWEVER, NO PATIENT INJURY WAS REPORTED. THE TIP FELL INTO THE SURGICAL FIELD AND WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642941 THUNDERBEAT 5MM, 20CM INLINE GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0520IC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR