BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP

    MDR report key: 2762998 · Received September 22, 2012

    Report

    Report Number
    8010047-2012-00325
    Event Type
    Other
    Date Received
    September 22, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 24, 2012
    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

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE PHYSICIAN PLACED THE SUBJECT DEVICE, WHICH WAS HEAT AFTER ACTIVATING, ON THE DRAPE COVERED THE PT'S ABDOMEN. AND THAT IT WAS BURN THE DRAPE AND THE PT'S ABDOMEN. THE TB-0535PC INSTRUCTION MANUAL ALREADY STATES: WARNING: TO PREVENT INJURY TO THE SURGEON, SURGICAL STAFF AND/OR PT DUE TO ACCIDENTAL ACTIVATION, DO NOT LEAVE THE THUNDERBEAT IN CONTACT WITH THE PT OR A FLAMMABLE OBJECT, SUCH AS A DRAPE, WHILE NOT IN USE. ALSO DO NOT LEAVE THE INSTRUMENT IN CONTACT WITH A TISSUE, THAT PT OR A FLAMMABLE OBJECT, SUCH AS A DRAPE, AFTER THE OUTPUT HAS CEASED. OTHERWISE, UNINTENTIONAL BURNS OF THE SURGEON, SURGICAL STAFF AND/OR PT OR A FIRE HAZARD MAY RESULT. IF ADDITIONAL INFO IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A GASTRIC BYPASS PROCEDURE, THE PHYSICIAN DIRECTLY PLACED THE SUBJECT DEVICE ON THE DRAPE OF THE PT'S ABDOMEN. WHEN THE DRAPE WAS UNCOVERED, IT WAS APPARENT THAT THE SUBJECT DEVICE HAD LEFT A SUPERFICIAL BURN MARK ON THE PHYSICIAN'S ABDOMEN. THE PHYSICIAN DIDN'T USE AN INSTRUMENT HOLDER. THE PHYSICIAN INSPECTED THE BURN, BUT DID NOT PRESCRIBE ANY ADDITIONAL TREATMENT. THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS THUNDERBEAT 5MM, 35CM, PISTOL GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535PC 22K

    Patients

    Seq Age Sex Outcome Treatment
    1