BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 5572882 · Received April 13, 2016

    Report

    Report Number
    8010047-2016-00528
    Event Type
    Malfunction
    Date Received
    April 13, 2016
    Date of Event
    March 7, 2016
    Report Date
    April 13, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE TISSUE PAD WAS WORN SEVERELY. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. THIS TYPE OF TISSUE PAD DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE TISSUE PAD WAS SEVERELY WORN WHEN THE USER CONTINUED TO ACTIVATE SEAL & CUT MODE WITHOUT CONTACTING TISSUE (INCLUDING AFTER THE TISSUE ALREADY CUT). THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY STATES. WARNINGS: DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING UNKNOWN OPERATION. IT WAS REPORTED THAT NEAR THE END OF THE OPERATION, A REGISTRAR STARTED USING THE DEVICE AND CONTINUED ACTIVATION AFTER TISSUE WAS TRANSECTED TO STOP OVER ACTIVATING. AS A RESULT, THE TISSUE PAD WAS WORN. TO TAKE PRECAUTION, THE DEVICE WAS REPLACED TO ANOTHER SAME DEVICE AND THE OPERATION WAS CONTINUED. IT WAS NOT REPORTED WHETHER THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED DEVICE. AND AS A RESULT OF OMSC'S INVESTIGATION ON APRIL 5, 2016, IT WAS FOUND THAT THE TISSUE PAD WAS WORN SEVERELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228422 SONICBEAT 5MM 35CM FRONT-ACTUATED GRIP SONICBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. SB-0535FC 57K

    Patients

    Seq Age Sex Outcome Treatment
    1