BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP

    MDR report key: 3063211 · Received February 26, 2013

    Report

    Report Number
    8010047-2013-00067
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    December 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE RPTR TO OBTAIN MORE INFO REGARDING THIS REPORT WITH NO RESULT. AN OLYMPUS SALES REP FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THAT THE SUBJECT DEVICE WAS USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY. IN THE MIDDLE OF THE CASE, THE USER NOTICED THAT THE TIP OF THE PROBE BROKE OFF. THE TIP WAS LOCATED OUTSIDE THE PT ON THE FLOOR. PER DISCUSSION WITH THE FACILITY, IT WAS NOTED THAT THE STAFF MIGHT BE USING TOO MUCH FORCE DURING CLEANING OF THE DEVICE. THE SR REVIEWED WITH THE STAFF THE PROPER CLEANING TECHNIQUE FOR THESE DEVICES. IN ADDITION, THE SR REVIEWED WITH THE USER THE CORRECT AND PROPER USE OF THE DEVICES TO PREVENT DAMAGE TO THE PROBES. THERE WAS NO REPORT OF PT INJURY. THE SUBJECT WAS NOT RETURNED TO OLYMPUS FOR EVAL AS IT'S STILL UNDER INVESTIGATION BY THE USER FACILITY. 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 REC'D A MEDWATCH REPORT THAT STATED THE FOLLOWING: "THE THUNDERBEAT DEVICE BROKE DURING A SURGICAL PROCEDURE. THERE WAS NO PT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81934 OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP THUNDERBEATH HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK