BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX, INC.

    MDR report key: 2271992 · Received September 28, 2011

    Report

    Report Number
    3007593903-2011-00004
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    June 21, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K022856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GENERATOR SOLID PATIENT PLATE INDICATOR WAS LIT AT POWER UP EVEN WITHOUT A PATIENT PLATE ATTACHED TO THE GENERATOR CONNECTION. WITH A SPLIT PAD INSTALLED, THE GENERATOR INDICATED (AND SENSED) A SOLID PLATE. IN SOLID PLATE MODE, THE UNIT ONLY SEES THAT A PATIENT PLATE IS HOOKED UP, CANNOT TELL IF A PATIENT IS ATTACHED TO THE PAD OR NOT AND CANNOT DETERMINE THE CONTACT RESISTANCE (PATIENT CONTACT TO PAD QUALITY). IN THE SOLID PAD MODE THE NEM (CONTACT MONITORING MODULE) CIRCUIT WAS INDICATING THAT A SOLID PLATE WAS HOOKED UP, DISPLAYED THAT INFORMATION ON THE FRONT PANEL BY LIGHTING THE SOLID PAD INDICATOR AND DID NOT PREVENT ACTIVATION OF THE UNIT. TEST AND INSPECTION OF THE GENERATOR DETERMINED THAT AN AMPLIFIER (U13) IN THE NEM CIRCUIT WAS DEFECTIVE. AFTER REPLACING THE AMPLIFIER AND CALIBRATING THE NEM, A COUPLE OF THE READINGS WERE ONE TO TWO OHMS OUT OF SPEC. FURTHER INSPECTION DETERMINED THAT THE CONFIGURATION PROM WAS CAUSING THE NEM READING TO BE SLIGHTLY OUT OF SPECIFICATION. REPLACING THE CONFIGURATION PROM CORRECTED THIS PROBLEM AND THE NEM WAS RECALIBRATED. RANDOM COMPONENT FAILURE IN THIS 6 YEAR OLD DEVICE CAUSED THE GENERATOR TO RECOGNIZE A SPLIT PATIENT PLATE AS A SOLID PLATE; THEREFORE THE SPLIT PATIENT PLATE CONTACT QUALITY MONITORING FUNCTION AND ASSOCIATED ALARM WAS NOT ACTIVE. DURING TYPICAL DEVICE SET UP PRIOR TO USE, THE PLATE SENSING INDICATOR SHOULD BE VERIFIED BY THE USER TO CORRECTLY RECOGNIZE THE TYPE OF ATTACHED PATIENT PLATE. ENHANCEMENT OF THE GENERATOR USER MANUAL WILL BE PROPOSED TO EMPHASIZE THE NEED FOR VERIFICATION BY THE USER.

    Description of Event or Problem · 1

    DURING A SHOULDER SURGICAL PROCEDURE, THE PATIENT'S SKIN WAS BURNED AT THE RETURN ELECTRODE ATTACHMENT SITE. THE ATTACHED RETURN ELECTRODE WAS SPLIT TYPE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX, INC. ELECTROSURGICAL GENERATOR GEI BOVIE MEDICAL CORPORATION AR-9600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BY 3M| RETURN ELECTRODE AND CORD (SPLIT), MANUFACTURED