BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPOLAR GOLD PROBE CABLE ADAPTER

    MDR report key: 1399937 · Received May 18, 2009

    Report

    Report Number
    1530493-2009-00003
    Event Type
    Other
    Date Received
    May 18, 2009
    Date of Event
    January 1, 2007
    Report Date
    May 18, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    PRE-AMEN
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS IN RESPONSE TO THE REPORT AS SUBMITTED BY BOSTON SCIENTIFIC, SEE THE UF/IMPORTER NUMBER. THIS INCIDENT WAS CORRECTED INTERNALLY AFTER RECEIPT OF THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007 THAT A BIPOLAR CABLE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED THE SAME DAY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR INDICATED BIPOLAR SETTING WAS ON AND ACTIVE, BUT THE GOLD PROBE DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH A SNARE (UNKNOWN DEVICE). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS "STABLE, FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPOLAR GOLD PROBE CABLE ADAPTER CABLE ADAPTER GEI OLSEN MEDICAL M00561360 001878

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK