BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR GOLD PROBE CABLE ADAPTER

    MDR report key: 1409293 · Received June 30, 2009

    Report

    Report Number
    1530493-2009-00006
    Event Type
    Other
    Date Received
    June 30, 2009
    Date of Event
    April 14, 2009
    Report Date
    June 29, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    PRE-AMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED IN JULY, 2006. BASED UPON COLLABORATION WITH THE CUSTOMER, THE DEVICE WAS USED BEYOND TWENTY TIMES.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A PT, AGE AND SEX UNK, A PHYSICIAN REQUESTED A GOLD PROBE TO COMPLETE THE PROCEDURE. THE GOLD PROBE CABLE ADAPTER, MANUFACTURED BY OLSEN MEDICAL, MATES WITH THE GOLD PROBE, MANUFACTURED BY ANOTHER DEVICE MANUFACTURER. THERE WAS NO ELECTRICITY AT THE DISTAL END OF THE PROBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THE PT WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR GOLD PROBE CABLE ADAPTER CABLE ADAPTER GEI OLSEN MEDICAL M00561360 002589

    Patients

    Seq Age Sex Outcome Treatment
    1 Other