BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYONICS RF-S CROSS 50 DEGREE PROBE WITH INTEGRATED C

    MDR report key: 2093981 · Received April 27, 2011

    Report

    Report Number
    2951580-2011-00058
    Event Type
    Other
    Date Received
    April 27, 2011
    Date of Event
    January 28, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K093165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED. THE VISUAL INSPECTION CONFIRMED THAT THE DEVICE SCREEN AT THE DISTAL END OF THE WAND WAS COMPLETELY GONE. THE VISUAL INSPECTION ALSO CONFIRMED EXTENSIVE ELECTRODE WEAR. A FUNCTIONAL TEST WAS PERFORMED. THE WAND FIRED IN SALINE, WITH WHAT WAS LEFT OF THE ELECTRODE. THE DEVICE WAS ACTIVATED AT DEFAULT SETTINGS AND MAXIMUM SETTINGS. THE SUCTION LINE WAS FOUND TO BE FUNCTIONAL. IN ADDITION, THE LOT HISTORY RECORD WAS REVIEWED. NO ABNORMALITIES WERE FOUND IN THE LOT HISTORY RECORD REVIEW. THE LOT MET ALL DEVICE SPECIFICATIONS. THE ROOT CAUSE OF THE FAILURE WAS FOUND TO BE FROM EXCESSIVE USE. THE DEVICE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING PRECAUTIONS: DYONICS RF PROBES ARE NOT DESIGNED FOR PROLONGED ABLATION OF SOFT TISSUE. DYONICS RF PROBES ARE DESIGNED FOR 3 TO 8 MINUTES OF CONTINUOUS USE AT THE DEFAULT SETTING. EXCESSIVE ABLATION MAY RESULT IN ELECTRODE WEAR. CHECK THE ELECTRODES INTERMITTENTLY TO ENSURE THEY ARE INTACT. STOP USING THE PROBE IF THE ELECTRODES SHOW EXCESSIVE WEAR. EXCESSIVE WEAR OF ELECTRODES MAY RESULT FROM VIGOROUS USE AGAINST BONY SURFACES.

    Description of Event or Problem · 1

    DURING A HIP ARTHROSCOPY PROCEDURE, USING DYONICS RF-S CROSS 50 DEGREE PROBE WITH INTEGRATED CABLE, THE TIP OF THE WAND REPORTEDLY FELL OFF. ALLEGEDLY, THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT IN THE SAME PROCEDURE. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 MINUTES. PROCEDURE WAS COMPLETED WITH NO ADVERSE REACTIONS TO THE PATIENT AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS RF-S CROSS 50 DEGREE PROBE WITH INTEGRATED C ELECTROSURGICAL CUTTING AND COAGULATION DE GEI ARTHROCARE CORP. 0411200-A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other