BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC SURGICAL SYSTEM SONOSURG

    MDR report key: 1853628 · Received September 29, 2010

    Report

    Report Number
    8010047-2010-00193
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE USER FACILITY WAS CONTACTED FOLLOWING THE EVENT TO GATHER ADDITIONAL INFORMATION, BUT COULD NOT IDENTIFY WHICH ONE OF MULTIPLE GENERATORS AT THE FACILITY HAD BEEN USED IN THE PROCEDURE. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF THE SUBJECT DEVICE IS RETURNED FOR EVALUATION, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS IN REFERENCE OF MFR REPORT # 8010047-2010-00192. OLYMPUS AMERICA INC. IS FILING MDRS ON BEHALF OF (B)(4) AND OLYMPUS MEDICAL SYSTEMS CORPORATION. (B)(4). THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC LYSIS OF ADHESION SURGERY, THE DISTAL TIP BROKE OFF, AND THE SONOSURG G2 GENERATOR REPORTEDLY DID NOT PROVIDE AN ALARM. THE SEPARATED PORTION OF THE DEVICE WAS RECOVERED DURING THE SAME PROCEDURE WITH GRASPERS. THE PROCEDURE WAS COMPLETED WITH ANOTHER SONOSURG PROBE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASONIC SURGICAL SYSTEM SONOSURG ELECTROSURGICAL UNIT FTJ OLYMPUS MEDICAL SYSTEM CORPORATION G-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1