BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 13302901 · Received January 20, 2022

    Report

    Report Number
    8010047-2022-01683
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 26, 2021
    Report Date
    March 10, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS EVALUATED AND INVESTIGATED BY OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THE TISSUE PAD WAS WORN OUT. IT WAS CONFIRMED THAT THE TISSUE PAD HAD FALLEN OFF. THE DEVICE HISTORY RECORD FOR THE LOT INDICATED NO ANOMALY WITH THE EVENT-RELATED ITEMS BELOW. INSPECTION] ULTRA-SONIC OUTPUT. INSPECTION] APPEARANCE. BASED ON THE RESULT OF CONFIRMING THE SUBJECT DEVICE AND THE INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE DETACHMENT OF THE TISSUE PAD MIGHT BE THE FOLLOWING: GRASPING SECTION WAS CLOSED WITHOUT GRASPING ANYTHING BETWEEN THE GRASPING SECTION AND THE DISTAL END OF THE PROBE WHILE ULTRASONIC OUTPUT WAS ACTIVATED (THIS INCLUDES AFTER TISSUE RESECTION). THIS MIGHT HAVE CAUSED THE TISSUE PAD TO WEAR OUT, AND IT WAS PARTIALLY PEELED OFF. A FORCE WAS APPLIED TO THE DETACHED TISSUE PAD, CAUSING IT TO TEAR AND PARTIALLY FELL OFF. NO OTHER INFORMATION COULD NOT BE OBTAINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A BIOMEDICAL ENGINEER THAT DURING A LAPAROSCOPIC SURGERY USING THE SUBJECT DEVICE WITH USG-400, THE TISSUE PAD WAS SEPARATED INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC SURGERY ON THE CECUM, THE SUBJECT DEVICE WAS USED. THERE WAS NO INJURY ON THE PATIENT AND THE MEDICAL STAFF IN THE EVENT. IT WAS NOT REPORTED THAT FRAGMENT REMAIN INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67480 SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP INSTRUMENT LFL OLYMPUS MEDICAL SYSTEMS CORP. SB-0535FC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown