BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 12132703 · Received July 7, 2021

    Report

    Report Number
    8010047-2021-08553
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 11, 2021
    Report Date
    July 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE PROBE WAS BROKEN OFF AT 16 MM FROM THE DISTAL END. THERE WAS SCRATCH AROUND THE BROKEN POINT. THE FRACTURE SURFACE OF THE PROBE SHOWED THAT CRACK DEVELOPED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE PROBE WAS CRACKED WHEN THE USER ACTIVATED OUTPUT CONTACTING WITH METAL OR SOMETHING HARD OBJECT SUCH AS METAL CLIPS, STAPLER, OR OTHER INSTRUMENTS, BESIDES THE PROBE WAS BROKEN OFF WHEN THE PROBE WAS SUBJECTED TO A LOAD. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING A RECTAL RESECTION USING THE SUBJECT DEVICE, THE PROBE WAS BROKEN OFF OUTSIDE THE PATIENT AFTER 2 HOURS AND MORE FROM THE START OF THE PROCEDURE. THERE WERE NO FALLEN FRAGMENTS INSIDE THE PATIENT. 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
    1023197 SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP INSTRUMENT LFL OLYMPUS MEDICAL SYSTEMS CORP. SB-0535FC 13K

    Patients

    Seq Age Sex Outcome Treatment
    1