BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 19805309 · Received July 23, 2024

    Report

    Report Number
    9614641-2024-01465
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 9, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LFL
    UDI-DI
    04953170370540
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D9, D10. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN A YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, IT IS LIKELY THE WORN-OUT TISSUE PAD ALONG WITH THE GRIPPERS NOT CLOSING ON THE TISSUE ON THE ULTRASOUND OUTPUT WHILE EMITTING THE ULTRASOUND LEADING TO THE TISSUE PAD WEAR LED TO THE MALFUNCTION. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ·DO NOT ACTIVATE OUTPUT 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 SEPARATION. DO NOT CLOSE THE GRIPPER AND PERFORM OUTPUT WHEN THERE IS NOTHING BEING GRIPPED BETWEEN THE GRIPPER AND THE TIP OF THE PROBE, OR WHEN IT IS NOT POSSIBLE TO CONFIRM THAT THE GRIPPED BIOLOGICAL TISSUE OR BLOOD VESSEL HAS BEEN INCISED. ABNORMAL HEAT GENERATION DUE TO FRICTION MAY RESULT IN DAMAGE, DEFORMATION, OR FALLING OFF OF THE GRIPPER AND PROBE TIP, OR PART OF THE TISSUE PAD MAY COME OFF, LEADING TO SEVERE WEAR. ·WHEN CUTTING OR VESSEL SEALING IS PERFORMED, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM THAT THEY ARE TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE TISSUE PAD, OR THE PROBE TIP MAY BREAK AND FALL, 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. ·WHEN TREATING BIOLOGICAL TISSUE OR BLOOD VESSELS, APPLY LIGHT TENSION TO MAKE THE INCISION SO THAT THE INCISION CAN BE SEEN. ALSO, ONCE THE INCISION IS COMPLETE, STOP OUTPUT IMMEDIATELY. OTHERWISE, ABNORMAL HEAT WILL BE GENERATED DUE TO FRICTION BETWEEN THE TISSUE PAD AND THE TIP OF THE PROBE, WHICH MAY LEAD TO DAMAGE, DEFORMATION, OR DETACHMENT OF THE GRIPPING PART (BOTH THE STAINLESS STEEL PART AND THE FLUORORESIN PART) AND THE TIP OF THE PROBE, OR PART OF THE TISSUE PAD MAY PEEL OFF. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE ULTRASONIC SURGICAL INSTRUMENT TISSUE PAD CAME OFF, IT DID NOT FALL INSIDE THE BODY. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480398 SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP INSTRUMENT LFL AOMORI OLYMPUS CO., LTD. SB-0535FC UNKNOWN 04953170370540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ULTRASONIC GENERATOR