BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER MULTIVAC 50 WITH INTEGRATED CABLE

    MDR report key: 1112163 · Received August 13, 2008

    Report

    Report Number
    2951580-2008-00057
    Event Type
    Other
    Date Received
    August 13, 2008
    Date of Event
    June 5, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K072865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IT WAS REPORTED THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. A REVIEW OF THE LOT HISTORY FOR THE DEVICE WAS PERFORMED. THE DEVICE MET ALL SPECIFICATIONS. THE INSTRUCTIONS FOR USE FOR THE DEVICE CONTAINS THE FOLLOWING PRECAUTION WHICH WARNS THE USER TO AVOID ALLOWING THE DEVICE CABLE TO COME IN CONTACT WITH THE PATIENT: "AS WITH OTHER ELECTROSURGICAL UNITS, ELECTRODES AND CABLES CAN PROVIDE PATHS FOR HIGH FREQUENCY CURRENT. POSITION THE CABLE TO AVOID CONTACT WITH PATIENT OR OTHER LEADS." SINCE THE DEVICE WAS NOT RETURNED, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED AND NO CONCLUSION COULD BE MADE.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING A SUPER MULTIVAC 50 WITH INTEGRATED CABLE ARTHROWAND WAS REPORTED TO ARTHROCARE CORPORATION. DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS REPORTED THE PATIENT SUSTAINED A BURN (SEVERITY NOT KNOWN) APPROXIMATELY 2 INCHES IN LENGTH AND 3 MM WIDE ON PATIENT'S CALF MUSCLE (ISOLATED FROM THE SURGICAL SITE). THE PHYSICIAN WAS NOT SURE WHAT CAUSED THE BURN. THE BURN WAS TREATED WITH DRESSINGS. IT WAS REPORTED THE PATIENT IS HEALING WELL AND PATIENT IS REPORTED TO BE DOING WELL. THE SURGEON INDICATED THE BURN MAY LEAVE A SCAR. THE PHYSICIAN ALSO REPORTED THAT THE WAND CABLE OR SUCTION LINE MAY HAVE COME IN CONTACT WITH THE PATIENT'S CALF DURING THE PROCEDURE, AND THE CAUSE OF THE BURN IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER MULTIVAC 50 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & CAOGULATION DEVICE GEI ARTHROCARE CORP. NA E936070-D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other