BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 6042619 · Received October 19, 2016

    Report

    Report Number
    8010047-2016-01363
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PTFE PAD WAS MISSING. IT WAS REPORTED THAT THE PAD OF THE DEVICE WAS DISCARDED BY THE USER. THE COATING OF GRASPING SECTION WAS PARTIALLY MISSING. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THIS TYPE OF THE PTFE PAD DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE PTFE PAD WAS DAMAGED WHEN THE USER CONTINUED TO ACTIVATE SEAL & CUT MODE WITHOUT CONTACTING TISSUE (INCLUDING AFTER THE TISSUE ALREADY CUT). THE DAMAGED PAD WAS SEPARATED WHEN IT RECEIVED A LOAD. THE INSTRUCTION MANUAL OF THE DEVICE ALREADY CAUTIONS; 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 PTFE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING. THIS REPORT IS ONE OF THE TWO REPORTS. CROSS REFERENCE MFR. REPORT NUMBER 8010047-2016-01380.

    Description of Event or Problem · 1

    DURING A PROCEDURE OF LOWER DIGESTIVE TRACT, THE SUBJECT DEVICE WAS USED. IT WAS REPORTED THAT THE PTFE PAD OF THE DEVICE WAS SEPARATED OUTSIDE THE PATIENT AFTER AN HOUR OF USE AND THE DEVICE COULD NOT BE USED ANY MORE. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT. THERE WAS NO PATIENT INJURY REPORTED. AFTER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE SUBJECT DEVICE FOR EVALUATION, OMSC CONFIRMED THAT THE COATING OF GRASPING SECTION WAS PARTIALLY MISSING ON) (B)(6) 2016. AND IT WAS NOT REPORTED THAT THE FRAGMENT OF THE COATING FELL INTO THE PATIENT. THIS MDR IS REGARDING THE SEPARATION OF THE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691407 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC 5ZK

    Patients

    Seq Age Sex Outcome Treatment
    1