BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP

    MDR report key: 2912843 · Received January 3, 2013

    Report

    Report Number
    8010047-2013-00002
    Event Type
    Other
    Date Received
    January 3, 2013
    Date of Event
    November 7, 2012
    Report Date
    December 3, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN MORE INFO REGARDING THIS REPORT. PER USER FACILITY, THE UNIT ALARMED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO FURTHER INFO AVAILABLE. OLYMPUS FOLLOWED UP WITH AN OLYMPUS SALES REP. PER THE SR, THE ALARM OCCURRED RIGHT WHEN THE USER ACTIVATED THE FOOT PEDAL. THE USER WAS OPERATING IN A POOL OF BLOOD AND WAS NOT ABLE TO VISUALIZE THE TISSUE (POTENTIALLY CAUSING THE TEFLON PAD TO COME IN CONTACT WITH PROBE). THERE WAS NO REPORT OF PT INJURY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BUT SIMILAR DEVICE. THIS PHENOMENON HAS OCCURRED IN 4 OUT OF APPROX 80 CASES PERFORMED AT THE USER FACILITY. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL DID NOT CONFIRM THE USER¿S EXPERIENCE. THE PROBE ON THE HANDPIECE PASSED THE PROBE CHECK WITHOUT ANY ERRORS. THERE WAS SOME TISSUE BUILD UP ON THE BASE OF THE PROBE. THE TEFLON PAS WAS MELTED AT THE TIP AND SLIGHTLY FRAYED AT THE CENTER. THE PROBE WAS INSPECTED UNDER A MICROSCOPE AND NO FRACTURES OR DENTS WERE FOUND. THERE WERE DEEP SCRATCHES ON THE PROBE TIP. THE PROBE ALSO HAD SOME DARK CHARRED STAINS. THE EXACT CAUSE OF THE USER¿S EXPERIENCE COULD NOT BE DETERMINED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THE INSTRUCTION MANUAL STATES ¿DO NOT ACTIVATED OUTPUT FOR AN EXTENDED PERIOD WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE BETWEEN THE GRASPING SECTION DURING THE SEAL AND CUT MODE MAY RESULT IN PREMATURE WEAR, BRAKEAGE AND/OR PROBE INSIDE THE BODY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THA ¿AN ¿OUT OF BOX¿ THUNDERBEAT INSTRUMENT ((B)(4)) FAILURE OCCURRED. NO LOT NUMBER WAS PROVIDED. THE CUSTOMER DID AN INTERNAL EVAL AND NOW WOULD LIKE OLYMPUS TO DO EVAL ON FAILED EQUIPMENT.¿ ON (B)(4) 2012, OLYMPUS RECEIVED A MEDWATCH REPORT STATING THAT ¿DURING A LAPAROSCOPIC-ASSISTED SEGMENT 6 HEPATIC RESECTION, THE TEFLON IN THE JAWS OF THE THUNDERBEAT HANDPIECE WAS STARTING TO COME OFF.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3787 OLYMPUS THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535PC 2JA030(24K)

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR