BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 13965653 · Received March 31, 2022

    Report

    Report Number
    8010047-2022-05445
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 1, 2022
    Report Date
    June 14, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170337574
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. CUSTOMER DID NOT PROVIDE ANY PATIENT AND PROCEDURE DETAILS ARE NOT PROVIDED. 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. LOT NUMBER KR178653 IS ACTUAL DEVICE LOT NUMBER; KR183134 IS PACKAGE LOT NUMBER. THE DEVICE IS RETURNED AND AN EVALUATION COMPLETED FOR IT. THE USER¿S COMPLAINT WAS CONFIRMED. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE FAILED THE PROBE CHECK WITH ERROR CODE U509. BOTH SWITCHES WERE CHECKED AND FOUND BOTH SWITCHES ARE FUNCTIONAL. A VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE; THERE IS SOME TISSUE BUILD UP LOCATED NEAR THE DISTAL END. THE PTFE TEFLON PAD (TISSUE PAD) WAS INSPECTED AND FOUND IT IS WORN ON CERTAIN PORTIONS ON THE SIDE; HOWEVER, NO METAL IS EXPOSED. THERE ARE SIGNS OF MINOR DRIED FOREIGN RESIDUE. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND THE PROBE IS DETACHED WITH MISSING PORTION RETURNED. THE DETACHED PROBE TIP WAS EXAMINED AND IT APPEARS THERE IS ALSO DRIED FOREIGN RESIDUE. THE WIPER MOVEMENT IS NORMAL. THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW IS NORMAL. THE HANDLE LOAD IS NORMAL. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH. THE EXACT CAUSE OF THE BROKEN PROBE COULD NOT BE DETERMINED. HOWEVER, BASED ON INVESTIGATION RESULTS THE PROBE MIGHT HAVE CONTACTED WITH OTHER SURGICAL INSTRUMENTS, OR NON-INSULATED AREA AS DESCRIBED BELOW. THIS MIGHT HAVE CAUSED THE PROBE TO BREAK. HARD TISSUE, A METAL OBJECT OR A SURGICAL INSTRUMENT HAD BEEN IN CONTACT WITH THE PROBE DURING THE OUTPUT ACTIVATION IN SEAL AND CUT MODE CAUSING THE SCRATCHES ON THE PROBE. THE DEVICE WAS ACTIVATED IN SEAL AND CUT MODE OR WHILE THE GRASPING SECTION WAS GRASPING TISSUE. THIS APPLIED A FORCE TO THE SCRATCHED AREA OF THE GRASPING SECTION, CAUSING THIS AREA TO HAVE CRACKS. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. OR, GRASPING SECTION WAS CLOSED WITHOUT GRASPING ANYTHING WHILE THE DEVICE WAS ACTIVATING IN SEAL AND CUT MODE (THIS INCLUDES AFTER TISSUE RESECTION) CAUSING THE TISSUE PAD TO WEAR OUT. SINCE THE TISSUE PAD WAS WORN OUT, NON-INSULATED AREA OF THE GRASPING SECTION AND THE DISTAL END OF THE PROBE CAME INTO CONTACT. THE OUTPUT WAS ACTIVATED IN SEAL AND CUT MODE IN STATE OF DESCRIPTION STATED ABOVE. THEREFORE, SCRATCHES (CONTACT MARKS) WERE MADE ON THE DISTAL END OF THE PROBE AND THE GRASPING SECTION, INDICATING THAT THEY CAME INTO CONTACT WITH EACH OTHER. THE DEVICE WAS ACTIVATED IN SEAL AND CUT MODE OR WHILE THE GRASPING SECTION WAS GRASPING TISSUE. THIS APPLIED A FORCE TO THE SCRATCHED AREA OF THE GRASPING SECTION, CAUSING THIS AREA TO HAVE CRACKS. A FORCE WAS APPLIED TO THE PROBE CAUSING IT TO BREAK. 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. THE THUNDERBEAT INSTRUMENT SHOULD BE USED FOR SOFT TISSUE. DO NOT ACTIVATE OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR HIGHLY CALCIFIED TISSUE, OR HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR, FORCEPS, AND OTHERS). OTHERWISE, IT MAY CAUSE THE PROBE TIP TO BE SCRATCHED OR COME INTO DIRECT CONTACT WITH THE METAL AREA OF THE GRASPING SECTION AS THE HEAT GENERATED BY THE FRICTION BETWEEN THE HARD OBJECT AND THE PROBE TIP COULD CAUSE WEAR/DEFORMING/SPLITTING/PROTRUDING/PARTIAL SEPARATING OF THE TISSUE PAD. IN TURN, THE PROBE MAY BREAK BEFORE DISPLAYING AN ERROR WINDOW OR GENERATING AN ALARM TONE. DO NOT GRASP OR LET THE PROBE TIP CONTACT HARD OBJECTS SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS (E.G., UTERINE MANIPULATOR). ALSO, BE CAREFUL TO AVOID CONTACTING THE PROBE TIP WITH THOSE ACCIDENTALLY. PARTICULARLY DURING ACTIVATION, A SCRATCH ON THE PROBE TIP COULD OCCUR DUE TO ULTRASONIC VIBRATION, WHICH LEADS THE PROBE TIP TO BREAK AND FALL OFF INTO THE BODY CAVITY. IN ADDITION, THE HIGH-FREQUENCY (RF BIPOLAR) CURRENT FLOWS THROUGH THE METAL AND GENERATES SPARK DISCHARGE, WHICH MAY CAUSE BURNS AND DECREASE FUNCTIONALITIES.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATE IN SECTION H6 - TYPE OF INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE CUSTOMER FOR THIS EVENT, DURING AN UNKNOWN THERAPEUTIC PROCEDURE, THE DEVICE TIP BROKE OFF IN THE PATIENT. THE SURGEON RETRIEVED THE TIP FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    ADDENDUM APR 25, 2022: THE EVENT OCCURRED IN THE BEGINNING OF THE PROCEDURE. PATIENT DID NOT NEED ADDITIONAL ANESTHESIA. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALIES NOTED. THERE WAS NO CABLE DAMAGE. THE CONNECTION POINTS TO THE GENERATOR WERE INSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104119 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC KR178653 04953170337574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown