BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 5030545 · Received August 25, 2015

    Report

    Report Number
    8010047-2015-00775
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 19, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT # 8010047-2015-00775 TO PROVIDE ADDITIONAL INFORMATION BASED ON THE EVALUATION OF THE DEVICE. LOT # WAS CORRECTED. DEVICE MANUFACTURER DATE WAS IDENTIFIED AND FILLED IN. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION. AS A RESULT OF EVALUATION OF OMSC ON AUGUST 28, 2015, OMSC CONFIRMED THAT THE PTFE PAD HAVE NOT BEEN BROKEN. BUT THE PROBE BROKE DOWN AT 14 MM FROM THE DISTAL END. THERE WERE CONTACT MARKS ON THE SURFACE OF THE PROBE AND THE JAW AT THE PROXIMAL END OF THE GRASPING SECTION. THE PTFE PAD WAS PARTIALLY WORN. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE CONTACT MARK AS THE STARTING POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS A RESULT OF THE INVESTIGATION, IT IS HIGHLY LIKELY THAT THE PTFE PAD WAS PARTIALLY WORN SINCE THE USER CONTINUED ACTIVATING OUTPUT WITHOUT CONTACTING TISSUE (INCLUDING AFTER THE TISSUE ALREADY CUT) OR ACTIVATED WITH GRASPING AND TWISTING TISSUE, AND CONSEQUENTLY THE PROBE CONTACTED WITH THE METAL PART OF THE JAW, AND BESIDES THE PROBE WAS CRACKED AND BROKEN. 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 PTFE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING AN UNCERTAIN PROCEDURE. THE PTFE PAD FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT DEVICE. THERE WAS NO PATIENT HARM REPORTED. OLYMPUS HAS FOLLOWED UP WITH USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, BUT WITH NO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561280 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC K4Z15

    Patients

    Seq Age Sex Outcome Treatment
    1