BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX, INC.

    MDR report key: 3338078 · Received September 5, 2013

    Report

    Report Number
    3007593903-2013-00002
    Event Type
    Injury
    Date Received
    September 5, 2013
    Date of Event
    July 26, 2013
    Report Date
    August 30, 2013
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K022856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE NOT ABLE TO DETERMINE A ROOT CAUSE THAT EXPLAINS THE ALLEGED PATIENT INJURY. AN INTERNAL POWER CIRCUIT COMPONENT WIRE WAS TOUCHING THE METAL SIDE OF ANOTHER COMPONENT. THIS DID NOT CAUSE THE UNIT TO FAIL ANY TEST SPECIFICATION. THE MODULE THAT MONITORS GROUNDING PAD ATTACHMENT (FOR EXPECTED PEELING) TO THE PATIENT MEASURED 141 OHMS, LOWER THAN THE SPECIFICATION RANGE OF 145 TO 155 OHMS. HAVING A LOWER THAN SPECIFIED RESISTANCE WOULD CAUSE THE PAD ATTACHMENT ALARM TO SOUND AT A LOWER RESISTANCE PROVIDING A LARGER SAFETY MARGIN. THE USER DID NOT REPORT A PROBLEM WITH THE ALARM. THE BIPOLAR OUTPUT CONNECTOR LOCATED ON THE FRONT PANEL HAD BOTH PLASTIC BARRELS MISSING. THIS IS A COSMETIC ISSUE AND WOULD NOT CAUSE OR CONTRIBUTE TO PATIENT INJURY.

    Description of Event or Problem · 1

    PATIENT RECEIVED A 3RD DEGREE BURN ON THE RIGHT THIGH DURING SHOULDER ARTHROSCOPY OF THE RIGHT SHOULDER. THE BURN DEVELOPED UNDER THE NEUTRAL ELECTRODE (GROUNDING PAD). THE CUSTOMER SAID ALL HAIR WAS REMOVED AND THE SKIN WAS DRY. OTHER DEVICES USED INCLUDED AN ABLATOR. THE ELECTROSURGICAL GENERATOR SETUP USED WERE CUT II, CUT 160, COAG 50, BIPOLAR 50, PINPOINT. NO CANNULA WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441417 ARTHREX, INC. ELECTROSURGICAL GENERATOR GEI BOVIE MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SPLIT PAD ABLATOR DEVICE: AR-9705A-90, LOT 565994| GROUNDING PAD (RETURN ELECTRODE): AR9610SGP