BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 12073497 · Received June 28, 2021

    Report

    Report Number
    8010047-2021-08040
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 1, 2021
    Report Date
    May 3, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LFL
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED, - THERE WAS A MARK ON THE PROBE THAT CAME INTO CONTACT WITH THE GRIP. - THE BROKEN PIECE OF THE GRASPING SECTION WAS NOT RETURNED. THE DEVICE HISTORY RECORD FOR THE LOT INDICATED NO ANOMALY WITH THE EVENT-RELATED ITEMS BELOW. [INSPECTION] ULTRASONIC OUTPUT. [INSPECTION] APPEARANCE. BASED ON THE INVESTIGATION RESULTS IN THE PAST, A LIKELY CAUSE OF THE DETACHMENT OF THE GRASPING SECTION AT THE REAR END MIGHT BE THE FOLLOWING MECHANISM. 1) THE TISSUE WAS GRASPED AT THE DISTAL END OF THE GRASPING SECTION, AND ULTRASONIC OUTPUT WAS ACTIVATED WHILE THE PROBE WAS IN CONTACT WITH THE TISSUE PAD AT THE REAR END OF THE GRASPING SECTION. 2) THE TISSUE PAD IS HEAVILY WORN. 3) SINCE THE TISSUE PAD WAS OUTPUT IN A STATE OF BEING SEVERELY WORN, CONTACT MARKS WERE GENERATED BETWEEN THE PROBE AND THE GRIP. 4) SINCE THE OUTPUT WAS ACTIVATED WHILE THE REAR END OF THE GRASPING SECTION WAS IN CONTACT WITH THE PROBE, A FORCE MIGHT HAVE APPLIED TO THE GRASPING SECTION AS BELOW. AS A RESULT, THE GRASPING SECTION BROKE AT THE CONTACT MARK. (A) ULTRASONIC VIBRATION DUE TO ULTRASONIC OUTPUT. (B) HEAT WAS REPEATEDLY APPLIED TO THE GRASPING SECTION DUE TO ULTRASONIC VIBRATION, AND THE GRASPING SECTION EXPANDED AND CONTRACTED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO G2. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENTS YOU POINTED OUT OCCURRED BY THE FOLLOWING MECHANISMS. 1) THE TISSUE WAS GRASPED AT THE TIP OF THE GRASPING PART, AND ULTRASONIC WAVES WERE OUTPUT WITH THE PROBE AND THE TISSUE PAD IN CONTACT AT THE REAR END OF THE GRASPING PART. 2) THE TISSUE PAD WAS SEVERELY WORN. 3) SINCE THE TISSUE PAD WAS OUTPUT IN A SEVERELY WORN STATE, CONTACT MARKS OCCURRED BETWEEN THE PROBE AND THE GRIPPING PART. 4) WHEN THE OUTPUT WAS PERFORMED WITH THE REAR END OF THE GRASPING PART AND THE PROBE IN CONTACT, THE FOLLOWING LOAD WAS APPLIED TO THE GRASPING PART, SO THAT THE GRASPING PART BROKE AT THE BASE POINT OF THE CONTACT MARK AND FELL OFF. THE EVENT CAN BE DETECTED/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 SEPARATING. DO NOT CLOSE THE GRIPPING PART AND OUTPUT WHEN NOTHING IS GRASPED BETWEEN THE GRASPING PART AND THE PROBE TIP, OR WHEN IT IS NOT POSSIBLE TO CONFIRM WHETHER THE LIVING TISSUE OR BLOOD VESSEL BEING GRASPED HAS BEEN INCISED. DUE TO ABNORMAL HEAT GENERATION CAUSED BY FRICTION BETWEEN THE GRIPPING PART AND THE PROBE TIP, THE GRIPPING PART AND THE PROBE TIP MAY BE DAMAGED, DEFORMED, OR FALLING OFF, AND PART OF THE TISSUE PAD MAY PEEL 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 LIVING TISSUES OR BLOOD VESSELS, MAKE AN INCISION WITH LIGHT TENSION SO THAT THE INCISION CAN BE SEEN. ALSO, WHEN IT IS CUT OFF, STOP THE OUTPUT IMMEDIATELY. OTHERWISE, ABNORMAL HEAT GENERATION DUE TO FRICTION BETWEEN THE TISSUE PAD AND THE PROBE TIP MAY LEAD TO DAMAGE, DEFORMATION, OR DISCONNECTION OF THE GRIPPING PART (BOTH THE STAINLESS-STEEL PART AND THE FLUOROPOLYMER PART) AND THE PROBE TIP, OR A PART OF THE TISSUE PAD MAY PEEL OFF". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION OF OMSC THE FOLLOWING WAS CONFIRMED, THE PRODUCT NAME WAS SB-0535FC. LOT NO. 11K SUPPLEMENTARY INFORMATION WAS 18. THE TISSUE PAD WAS HEAVILY WORN. THE GRIP WAS PARTIALLY MISSING. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM DISTRIBUTOR THAT ABOUT AN HOUR AFTER STARTING THE APPENDAGE REMOVAL, THE TISSUE PAD OF THE DEVICE HAD PEELED OFF THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970048 SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP INSTRUMENT LFL AOMORI OLYMPUS CO., LTD. SB-0535FC 11K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female