BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAC DISPOSABLE ACTIVE CORD

    MDR report key: 113456 · Received August 15, 1997

    Report

    Report Number
    113456
    Event Type
    Other
    Date Received
    August 15, 1997
    Date of Event
    August 13, 1997
    Report Date
    August 14, 1997
    Manufacturer
    CIRCON ACMI
    Product Code
    FFZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    77 YR OLD MALE PT UNDERGOING TRANSURETHRAL PROSTATE RESECTION, REC'D SMALL (2CM) RF BURN IN SCROTAL AREA FROM CUT AN INSULATION OF DISPOSABLE ACTIVE CORD. ANTISEPTIC OINTMENT APPLIED AND NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAC DISPOSABLE ACTIVE CORD ACTIVE ESU CORD FFZ CIRCON ACMI DAC *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other