BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC SURGICAL SYSTEM SONOSURG

    MDR report key: 1853618 · Received September 29, 2010

    Report

    Report Number
    8010047-2010-00192
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Adverse Event
    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. USER FACILITY PERSONNEL PROVIDED CONFLICTING INFORMATION AS TO THE LOCATION OF THE DEVICE AT THE HOSPITAL. 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 # 8010047-2010-00193. (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. 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 PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASONIC SURGICAL SYSTEM SONOSURG SONOSURG SCISSORS 5 MM O.D., NON HF LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3775 NA

    Patients

    Seq Age Sex Outcome Treatment
    1