BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 11795901 · Received May 10, 2021

    Report

    Report Number
    8010047-2021-06057
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 3, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LFL
    PMA / PMN Number
    K111202
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BEING SUBMITTED AS A CORRECTION TO THE FOLLOWING SECTIONS: B1, B2, D8, H1, H6.

    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. A PART OF THE GRASPING SECTION WAS MISSING. THE TISSUE PAD WAS WORN AND PARTIALLY TORN. THERE WAS A MARK ON A GRASPING SECTION THAT CAME INTO CONTACT WITH A PROBE TIP. THE BROKEN PIECE OF THE GRASPING SECTION WAS NOT RETURNED. THERE WAS A MARK ON THE PROBE THAT CAME INTO CONTACT WITH THE GRIP. WE CONFIRMED THE MISSING TISSUE PAD. WHEN WE PERFORMED PROBE CHECK WITH USG-400 AND TD-SB400 OWNED BY AOMORI OLYMPUS, NO ABNORMALITY OCCURRED. 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. 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. THE TISSUE PAD WAS WORN AND A PART OF IT WAS TORN. THE TISSUE PAD FELL OFF DUE TO THE LOAD APPLIED TO THE TORN TISSUE PAD. THE OUTPUT WAS ACTIVATED WITH THE WORN TISSUE PAD. THEREFORE, THE PROBE CAME INTO CONTACT WITH THE GRASPING SECTION. THIS CAUSED A CONTACT MARK AT THE PROBE AND THE GRASPING SECTION. 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. ULTRASONIC VIBRATION DUE TO ULTRASONIC OUTPUT. HEAT WAS REPEATEDLY APPLIED TO THE GRASPING SECTION DUE TO ULTRASONIC VIBRATION, AND THE GRASPING SECTION EXPANDED AND CONTRACTED. AS A RESULT OF CHECKING THE INSTRUCTION MANUAL, THE FOLLOWING DESCRIPTIONS RELATED TO THIS EVENT WERE FOUND. THIS EVENT IS WARNED BY THE INSTRUCTION MANUAL. DRAWING NUMBER AND REVISION NUMBER OF IFU: RC2058 05. 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE NON-HEALTHCARE PROFESSIONAL THAT DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY USING THE SUBJECT DEVICE, THE TISSUE PAD WAS WORN PARTIALLY AND BROKEN OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693233 SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP INSTRUMENT LFL AOMORI OLYMPUS CO., LTD. SB-0535FC 0ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention