BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP

    MDR report key: 3191194 · Received June 24, 2013

    Report

    Report Number
    8010047-2013-00159
    Event Type
    Other
    Date Received
    June 24, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 29, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP TO OBTAIN MORE INFO REGARDING THIS REPORT. THE PHYSICIAN HAD USED THE THUNDERBEAT ONCE BEFORE DURING OPEN SURGERY, THUS HE USED IT FIRST TIME DURING A LAPAROSCOPIC SURGERY. OLYMPUS (B)(4) INVESTIGATED THE ULTRASONIC GENERATOR ((B)(4)) AND THE ELECTROSURGICAL UNIT ((B)(4)), AS THE RESULT THERE WAS NO PROBLEM. THE SUBJECT DEVICE WAS DISCARDED BY THE USER FACILITY. THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THE EXACT CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED DUE TO THE ABSCENCE OF THE DEVICE TO INVESTIGATE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    WHEN A PHYSICIAN USED THE SUBJECT DEVICE FOR A LAPAROSCOPIC LIVER RESECTION, THE PHYSICIAN SAID THAT THE THUNDERBEAT DID NOT SEEM VERY HEMOSTASIS ESPECIALLY BECAUSE AT THE TIME HE WAS ONLY RESECTING VERY SUPERFICIALLY ON THE LIVER. THE PHYSICIAN CAME ACROSS A VESSEL NO BIGGER THAN 4 MM, HE USED THE SEAL AND CUT OUTPUT ACROSS THE VESSEL AND THE THUNDERBEAT CUT RIGHT THROUGH IT WITHOUT SEALING IT AT ALL. THIS RESULTED IN HEAVY BLEEDING. THE PHYSICIAN USED THE SEAL OUTPUT TO CONTROL THE BLEEDING BUT THIS WAS HAVING NO EFFECT. CONTINUOUSLY, THE PHYSICIAN USED A BIPOLAR FORCEPS, WHICH WAS PLUGGED INTO THE SAME ELECTROSURGICAL UNIT OF THE THUNDERBEAT, AND SOME CLIP TO CONTROL THE BLEEDING. THE PHYSICIAN COMPLETED THE PROCEDURE BY USING A STAPLE DEVICE. THE LENGTH OF THE PROCEDURE WAS INCREASED FROM 1.5 - 2 HOURS TO MORE LIKE 4 HOURS. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284969 OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC 28K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other