BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 45 CM, PISTOL GRIP

    MDR report key: 2925289 · Received January 11, 2013

    Report

    Report Number
    8010047-2013-00007
    Event Type
    Other
    Date Received
    January 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS 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 INFORMATION REGARDING THIS REPORT. PER THE USER FACILITY, THE DEVICE MALFUNCTIONED DURING THE PROCEDURE. THERE WAS NO FURTHER INFORMATION AVAILABLE. OLYMPUS FOLLOWED UP WITH THE INDEPENDENT OLYMPUS REPRESENTATIVE THAT WAS PRESENT AT THE CASE. PER THE REP, THE ISSUE OCCURRED DURING A DA VINCI ROBOTIC DISTAL PANCREATECTOMY. THE SURGEON WAS ACTIVATING THE SEAL AND CUT BUTTON WITHOUT TISSUE IN THE JAW FOR ABOUT 8-10 SECONDS WITH FULL GRASP CAUSING THE TEFLON TO SLIGHTLY CHAR. THE SURGEON CONTINUED THE PROCEDURE WITH THE SAME DEVICE UNTIL THE TEFLON STARTED TO COME LOOSE FROM THE JAW. THE DEVICE WAS REMOVED WITH THE TEFLON INTACT. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR BUT DIFFERENT DEVICE. THE REP IS WORKING WITH THE USERS ON CORRECT AND PROPER USE TO PREVENT DAMAGE TO THE PROBES AND TEFLON PADS. THE SUBJECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. USER ERROR CANNOT BE RULED OUT AS A CAUSATIVE FACTOR. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THE INSTRUCTION MANUAL PROVIDES THE FOLLOWING WARNING "DO NOT ACTIVATE 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 & CUT MODE MAY RESULT IN PREMATURE WEAR, BREAKAGE AND/OR PROBE INSIDE THE BODY CAVITY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE TEFLON INSERT MELTED INSIDE THE PATIENT. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16370 OLYMPUS THUNDERBEAT 5 MM, 45 CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0545PC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK