BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 14917321 · Received July 5, 2022

    Report

    Report Number
    8010047-2022-11333
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 8, 2022
    Report Date
    September 22, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THIS EVENT TO THE (B)(6). THE DEVICE HAS BEEN RETURNED BUT THE DEVICE EVALUATION IS NOT YET COMPLETED. AS SUCH, A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS ANY RELEVANT NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATES IN SECTIONS H3, H4, H6, AND H10. THE DEVICE WAS RETURNED AND AN EVALUATION WAS COMPLETED FOR IT. DURING INSPECTION, OLYMPUS CONFIRMED THE REPORTED EVENT, THE TISSUE PAD WAS FOUND TO BE MISSING. ADDITIONALLY, THERE WAS A MARK ON THE PROBE, THE COATING OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF, AND AN ERROR CODE WAS NOTED; HOWEVER, THESE DEFECTS ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: 1. DUE TO PERFORMING OUTPUT WHILE GRASPING NOTHING (INCLUDING THE CASE THE USER KEPT ACTIVATING AFTER CUTTING TISSUE), THE DISTAL END OF THE TISSUE PAD WAS PEELED AWAY. 2. THE TISSUE PAD WAS FELL OFF DUE TO LOAD APPLIED TO THE PEELING TISSUE PAD. OR 1. THE WORN OF THE TISSUE PAD COULD HAVE HAPPENED BECAUSE ¿ SEAL & CUT¿ OUTPUT WAS ACTIVATED WHILE GRASPING NOTHING WITH THE GRASPING SECTION AND THE PROBE TIP, OR KEPT ACTIVATING THE OUTPUT AFTER A TRANSECTION OF TISSUE. 2. THE TISSUE PAD WAS WORN AWAY, CAUSING THE NON-INSULATED AREA OF THE GRASPING SECTION TO TOUCH THE PROBE. 3. THE SEAL & CUT OUTPUT WAS ACTIVATED WITH THE NON-INSULATED AREA OF THE GRASPING SECTION TOUCHING THE PROBE. THIS CAUSED THE ERROR AND THE CONTACT MARKS ON THE NON-INSULATED AREA OF THE GRASPING SECTION AND THE PROBE. THIS FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿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.¿ ¿WHEN CUTTING AND VESSEL SEALING IS PERFORMED IN SEAL & CUT MODE, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM IT IS TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE TISSUE PAD, OR THE PROBE TIP MAY BREAK AND FALL OFF, AND PARTIAL SEPARATING OF THE TISSUE PAD MAY OCCUR DUE TO A LOCAL INCREASE OF TEMPERATURE CAUSED BY THE FRICTION BETWEEN TISSUE PAD AND THE PROBE TIP DURING ACTIVATION.¿ ¿IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STICKED TISSUE DURING TREATMENT, WIPE IT WITH A SOFT OBJECT SUCH AS A PIECE OF GAUZE OR A BRUSH. DO NOT ATTEMPT TO SCRAPE IT WITH A SHARP OBJECT SUCH AS A SCALPEL OR THE TIP OF TWEEZERS. OTHERWISE, THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT, THE FLUORINE RESIN PART, A COATED SURFACE OR THE PROBE TIP MAY BE SCRATCHED AND DAMAGED, WHICH MAY LEAD TO FALL-OFF OF THE DAMAGED PART INTO THE BODY CAVITY OR BURNS OF THE TISSUE BY A HIGH-FREQUENCY LEAK CURRENT OUTPUT DUE TO DESTRUCTION OF THE INSULATION STRUCTURE.¿ OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, AFTER APPROXIMATELY AN HOUR OF USE DURING A THERAPEUTIC LEFT COLON PROCEDURE, THE DEVICE TEFLON PAD PEELED BACK. NO PIECE OF THE TEFLON PAD FELL OFF. THE NURSE REMOVED THE TEFLON PAD FROM THE DEVICE ON THE SERVICE CART. AN U508 SHORT CIRCUIT ERROR MESSAGE WAS RECEIVED FOR THE DEVICE AT THE TIME OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH A FIVE MINUTE DELAY USING A THIRD-PARTY DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. INTELLIGENT TISSUE MONITORING FUNCTIONALITY (ITM) WAS ON AS IS USUAL. THE USER UNDERSTANDS THAT THE ITM IS A SUPPORT FUNCTIONALITY, AND THAT IT IS POSSIBLE THAT THE ITM MAY NOT ALWAYS DETECT THE TISSUE ALREADY CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366677 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR176759 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown USG-400 VERSION 2.00