BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP

    MDR report key: 3202268 · Received June 28, 2013

    Report

    Report Number
    8010047-2013-00216
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE REFERENCED DEVICE WAS EVAL WITH AN ESG-400, AN USG-400, AND THE TD-TB400 TRANSDUCER WITH NO SPARKING AND NO ALARM NOTED DURING EVAL. THE DEVICE PASSED THE PROBE CHECK. THERE WAS DARK CHARRED STAIN FOUND ON THE TEFLON PAD AND ON THE PROBE TIP, AND THE TEFLON PAD WAS SLIGHTLY MELTED AT THE DISTAL END. THE MANIPULATION JAW WAS FOUND WITH MINOR TISSUE BUILDUP. THE WIPER MOVEMENT AND THE OPEN/CLOSE CONSISTENCY MOVEMENT OF THE JAW WAS NORMAL. THE JAW AND THE PROBE ALIGNED PROPERLY. THE HANDLE LOAD AND ROTATION KNOB TORQUE WERE FOUND WITHOUT ANY ISSUES. THE DEVICE HAD FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER EVAL. PLEASE ALSO CROSS REFERENCE 8010047-2013-00217.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LSH) PROCEDURE, THE FIRST HANDPIECE SPARKED AND THE SYS GENERATED AN ALARM. A DIFFERENT BUT SIMILAR HANDPIECE WAS SUBSEQUENTLY UTILIZED WHICH PRODUCED A PROBE DAMAGE ERROR. THE HANDPIECE WAS USED AGAIN AFTER IT PASSED THE PROBE CHECK AND THE TIP OF THE HANDPIECE BROKE OFF AND DISPLAYED AN "U509" ERROR CODE. THE INTENDED PROCEDURE WAS COMPLETED WITH A BIPOLAR SHEARS. THERE WAS NO PT HARM REPORTED. OLYMPUS FOLLOWED-UP TO OBTAIN ADDITIONAL INFO REGARDING THIS REPORT. THE FIRST HANDPIECE SPARKED WHILE THE DEVICE WAS INSIDE THE PT AND IT WAS REPLACED. DURING THE AMPUTATION OF CERVIX, THE SECOND HANDPIECE DISPLAYED PROBE DAMAGE ERROR TWICE AND PASSED THE PROBE CHECK BOTH TIMES. AS THE USERS CONTINUED WITH THE AMPUTATION, AN "U509" ERROR CODE REPORTEDLY DISPLAYED AND THE HANDPIECE WAS REMOVED FOR INSPECTION AGAIN. UPON FEELING THE PROBE, THE HANDPIECE BROKE. THE INTENDED PROCEDURE WAS COMPLETED USING MONOPOLAR SCISSORS AND A LYONS DISSECTING FORCEPS. THE PT REPORTEDLY WAS RELEASED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295095 OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC K3213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SILICONE UTERUS MANIPULATOR| OLYMPUS USG-400: SERIAL NUMBER (B)(4)| LYONS DISSECTING FORCEPS| ESG-400: SERIAL NUMBER (B)(4)