BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRE

    MDR report key: 1831282 · Received September 3, 2010

    Report

    Report Number
    3007593903-2010-00004
    Event Type
    Other
    Date Received
    September 3, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K001955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT AS A RESULT OF THE DISTRIBUTOR'S TEST REPORT WAS CONFIRMED. NEM CIRCUIT WAS NOT FUNCTIONAL AND GAVE AN INDICATION THAT A GROUNDING PAD/CABLE WAS ATTACHED TO THE GENERATOR EVEN THOUGH IT WAS NOT. BOVIE'S TESTING AND EVALUATION OF THE DEVICE SHOWED THAT A THIRD-PARTY REPAIR HAD BEEN ATTEMPTED (RESOLDERING) FOR COMPONENTS ON THE CIRCUIT BOARD. THE NEM MODULE HAD A DAMAGED COMPONENT THAT WAS DIRECTLY RELATED TO THE OBSERVED NON-CONFORMANCE.

    Description of Event or Problem · 1

    DURING TESTING PERFORMED BY A DISTRIBUTOR, THE FOLLOWING WAS FOUND: THERE WAS NO ALARM ON NEUTRAL ELECTRODE MONITORING (NEM) CIRCUIT. THE NEW GROUNDING PLATE INDICATOR (GREEN) STAYS LIT WITHOUT PT PLATE/CABLE CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRE ELECTROSURGICAL GENERATOR GEI BOVIE MEDICAL CORPORATION ASG-120 DR0807005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA