BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMEDICS 110-G ELECTROSURGICAL UNIT

    MDR report key: 44618 · Received October 4, 1996

    Report

    Report Number
    2522397-1996-00014
    Event Type
    Malfunction
    Date Received
    October 4, 1996
    Date of Event
    September 11, 1996
    Report Date
    October 4, 1996
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED IN THE ORIGINAL REPORT, THE USER ADMITTED THAT THE UNIT WAS OPERATED INCORRECTLY IN THAT THE GROUNDING PAD WAS NOT ATTACHED TO THE GENERATOR WHEN THE GENERATOR WAS ACTIVATED. THE USER STATED THAT THE PATIENT RECEIVED A SHOCK WHEN THE UNIT WAS ACTIVATED. UPON RECEIPT OF THE UNIT, IT WAS TESTED ACCORDING TO THE USERS MANUAL WITH PARTICULAR ATTENTION PAID TO THE EXPECTED WARNING LIGHT AND OUTPUT POWER SHUT OFF WHEN THE GROUNDING PAD WAS DISCONNECTED. IN ALL CASES, WHEN THE GROUNDING PAD WAS DISCONNECTED, THE WARNING LIGHT WAS OBSERVED TO LIGHT AND THE OUTPUT POWER CEASED. THE SITUATION THAT THE USER EXPERIENCED COULD NOT BE DUPLICATED. THIS MODEL OF ELECTROSURGERY GENERATOR IS GROUND REFERENCED. IT IS POSSIBLE TO DELIVER POWER TO THE PATIENT IF THE GROUNDING PAD IS CONNECTED TO THE GENERATOR BUT NOT TO THE PATIENT AND THE PATIENT IS AT GROUND POTENTIAL. IT MAY BE THAT THIS WAS THE ACTUAL CONFIGURATION AT THE TIME OF THE INCIDENT, AND NOT AS INITIALLY REPORTED. THE UNIT PERFORMS EXACTLY AS DESIGNED IN SUCH A SITUATION.

    Description of Event or Problem · 1

    PT RECEIVED A SHOCK DURING A GYNECOLOGICAL PROCEDURE. ACCORDING TO THE BIOMEDICAL ENGINEER, THE GROUNDING PAD WAS INADVERTENTLY NOT CONNECTED TO THE GENERATOR WHEN THE GENERATOR WAS ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOMEDICS 110-G ELECTROSURGICAL UNIT ELECTROSURGERY GENERATOR GEI CABOT MEDICAL CORP. 110-G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *