BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS RF-S WHIRLWIND 90 DEG

    MDR report key: 5025940 · Received August 24, 2015

    Report

    Report Number
    3006524618-2015-00501
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    BWA
    PMA / PMN Number
    K090393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND MODERATE ELECTRODE WEAR WITH DISCOLORATION ON THE RETURN CAP AND AROUND THE SPACER. FUNCTIONAL ASSESSMENT OF THE RETURNED DEVICE FOUND THAT THE DEVICE PERFORMED AS INTENDED AND SALINE FLOWED THROUGH-OUT THE SUCTION LINE WITHOUT HESITATION. THE PHOTOGRAPHIC EVIDENCE SHOWS THAT THE PATIENT'S BURN IS LOCATED ON THE INSIDE OF THE ARM, SUGGESTING THAT THE SUCTION LINE OR THAT THE SECONDARY SOURCE FOR OUTFLOW WAS POSITIONED INCORRECTLY. THE PHOTOGRAPHIC EVIDENCE CONFIRMS THE PATIENT¿S ARM HAS A DERMAL BURN THAT WOULD BE CONSISTENT WITH THE USER NOT FOLLOWING THE IFU. ADDITIONAL FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT COULD BE RELATED TO INADEQUATE FLOW AND CIRCULATION OF SALINE SOLUTION OR IMPROPER SUCTION. OTHER POTENTIAL FACTORS ARE LISTED IN THE IFU AND DEVICES USER MANUAL, WHICH CONTAINS PRECAUTIONARY AND WARNINGS TO ADHERE TO DURING ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE USING A DYONICS RF-S WHIRLWIND 90 DEGREE PROBE, THE PATIENT SUSTAINED A MINOR DERMAL BURN. THE BURN WAS TREATED WITH GAUZE AFTER THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559110 DYONICS RF-S WHIRLWIND 90 DEG ELECTROSURICAL, CUTTING, COAGULATION BWA ARTHROCARE CORP. 1092596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention