BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13639244 · Received March 1, 2022

    Report

    Report Number
    8010047-2022-03729
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    November 23, 2021
    Report Date
    December 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS RETURNED AND AN EVALUATION COMPLETED FOR IT. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA AT INSPECTION. UPON INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT TEFLON PAD (TISSUE PAD) IN THE GRASPING SECTION WAS WORN ALONG WITH A PART OF THE TISSUE PAD BEING PEELED AWAY. THERE WAS A MARK IN THE NON-INSULATED AREA OF GRASPING SECTION WHICH CAME IN CONTACT WITH THE PROBE AND WAS ABRADED AGAINST IT. THERE WAS A MARK IN THE PROBE WHICH CAME IN CONTACT TO THE NON-INSULATED AREA OF GRASPING SECTION AND WAS ABRADED AGAINST IT. THE COATING OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF. THE COATING OF THE PROBE WAS PARTIALLY PEELING. THE EXACT CAUSE OF THE ISSUE CANNOT BE EXCLUSIVELY IDENTIFIED. HOWEVER BASED ON THE DEVICE EVALUATION AND PAST INVESTIGATION RESULTS, IT IS LIKELY THE SHORT CIRCUIT ERROR AND THE PEELING OF THE TISSUE PAD OCCURRED BY THE FOLLOWING MECHANISM: 1. THE WEARING AND PARTIAL PEELING OF THE TISSUE PAD COULD HAVE HAPPENED BECAUSE SEAL AND 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 AND CUT OUTPUT WAS ACTIVATED WITH THE NON-INSULATED AREA OF THE GRASPING SECTION TOUCHING THE PROBE. THIS CAUSED THE CONTACT MARKS ON THE NON-INSULATED AREA OF THE GRASPING SECTION AND THE PROBE AND THE SHORT CIRCUIT ERROR OCCURRED. THE COATING OF THE GRASPING SECTION COULD HAVE COME OFF WHEN DIRT SUCH AS BURN WAS SCRAPED OFF WITH SOMETHING HARD. IT HAS BEEN CONFIRMED THAT THE PROBE COATING PEELS OFF IF THE DEVICE WAS HANDLED AS BELOW. HOWEVER, IT CANNOT BE CONCLUSIVELY DETERMINED IF SUCH HANDLING ACTUALLY CAUSED THE IT TO HAPPEN HERE. ¿ ACTIVATE THE DEVICE IN SEAL AND CUT MODE FOR A LONG DURATION WHILE NO TISSUE IS GRASPED BY THE GRASPING SECTION AND THE DISTAL END OF THE PROBE. ACTIVATION IN SEAL AND CUT MODE CONTINUED AFTER COMPLETION OF A TISSUE CUTTING IS ALSO INCLUDED IN SUCH ACTIVATION. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING STATEMENTS THAT WARN AGAINST THE ISSUE: ·DO NOT ACTIVATE OUTPUT IN SEAL AND 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 AND 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 TISSUE STUCK 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. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 23-NOV-2021.INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    WHEN THE DEVICE RETURNED BY THE CUSTOMER WAS EVALUATED, IT WAS OBSERVED THAT THE TEFLON PAD (TISSUE PAD) IN THE GRASPING SECTION OF THE DEVICE WAS WORN ALONG WITH A PART OF THE TISSUE PAD BEING PEELED AWAY. THE DEVICE WAS RETURNED BY THE CUSTOMER FOR MULTIPLE ALARMS BEING SOUNDED INTERMITTENTLY DURING A THERAPEUTIC LAPAROSCOPIC EXTENDED RIGHT HEMICOLECTOMY PROCEDURE AFTER APPROXIMATELY ONE AND A HALF TO TWO HOURS. THE ERROR MESSAGE SEAL - SHORT CIRCUIT ERROR WAS RECEIVED WITH EACH ATTEMPT TO SEAL AN ILEOCOLIC VESSEL. THE ERROR MESSAGE WAS BEING RECEIVED IN THE SEAL FUNCTION, THE SEAL AND CUT FUNCTION DID NOT HAVE AN ISSUE. THERE WAS NO APPARENT DAMAGE TO THE DEVICE; HOWEVER, THE DEVICE WAS REPLACED WITH A NEW ONE AS A PRECAUTION AND THE PROCEDURE COMPLETED WITHOUT ANY DELAY. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE INTELLIGENT TISSUE MONITORING (ITM) FEATURE WAS TURNED ON DURING THE PROCEDURE AS IS THE USUAL PRACTICE. THE USERS (SURGEON AND REGISTRAR) UNDERSTAND THE CHARACTERISTIC OF ITM, WHICH IS THAT ITM IS A SUPPORT FUNCTION, AND THERE IS A POSSIBILITY THAT ITM CANNOT DETECT THE TISSUE ALREADY CUT. THE USERS WERE NEW TO THE DEVICE AND WERE POTENTIALLY OVER-ACTIVATING NOT BEING USED TO THE SPEED OF THE DEVICE. HOWEVER, THE SURGEON IS HAPPY WITH THE PERFORMANCE OF THE DEVICE AND WILL USE THE DEVICE AGAIN FOR PROCEDURES. THIS MEDWATCH IS BEING SUBMITTED FOR THE TEFLON PAD (TISSUE PAD) IN THE GRASPING SECTION BEING WORN ALONG WITH A PART OF THE TISSUE PAD BEING PEELED AWAY OBSERVED DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389347 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR139673 04953170409677

    Patients

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