BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROVASIVE GOLD PROBE

    MDR report key: 2083636 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01577
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CONNECTOR BODY ASSEMBLY WAS PARTIALLY SEPARATED FROM THE CAP CONNECTOR. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE INNER DIAMETER OF THE CAP CONNECTOR AND OUTER DIAMETER OF THE CONNECTOR BODY ASSEMBLY; BOTH MEASUREMENTS WERE WITHIN SPECIFICATION. A FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE DEVICE RETURN CONDITION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE PROBE CONNECTOR BROKE INTO TWO PIECES. THE EVALUATION FOUND THAT THE ELECTRICAL CONNECTOR (BANANA PLUG) WAS NOT FULLY SNAPPED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE DEVICE WAS USED DURING PROCEDURE PERFORMED ON FOR HEMOSTASIS. ACCORDING TO THE COMPLAINANT, THE CONNECTOR FOR THE GOLD PROBE DEVICE BROKE INTO TWO PIECES, WHILE DISCONNECTING IT FROM THE BIPOLAR ADAPTOR CABLE. THIS OCCURRED AFTER THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GOLD PROBE DEVICE WAS USED DURING PROCEDURE PERFORMED ON FOR HEMOSTASIS. ACCORDING TO THE COMPLAINANT, THE CONNECTOR FOR THE GOLD PROBE DEVICE BROKE INTO TWO PIECES, WHILE DISCONNECTING IT FROM THE BIPOLAR ADAPTOR CABLE. THIS OCCURRED AFTER THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI M00560070 13453778

    Patients

    Seq Age Sex Outcome Treatment
    1