BEUDAMED
    FDA Adverse Event Death Summary report: N

    GOLD PROBE

    MDR report key: 282864 · Received June 23, 2000

    Report

    Report Number
    1051710-2000-00009
    Event Type
    Death
    Date Received
    June 23, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 31, 2000
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT OF AN ARTERIOVENOUS MALFUNCTION IN THE CECUM (COLON) WITH THE GOLD PROBE DEVICE (BIPOLAR ELECTROCAUTERY PROBE) A PERFORATION OCCURRED. PT WAS TAKEN TO SURGERY AT A LATER DATE AND SUBSEQUENTLY EXPIRED DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD PROBE ELECTROHEMOSTASIS CATHETER KNS BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death