BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASYS BIPOLAR ACTIVE/RETURN CORD

    MDR report key: 509948 · Received January 13, 2004

    Report

    Report Number
    1527736-2004-00080
    Event Type
    Malfunction
    Date Received
    January 13, 2004
    Report Date
    January 5, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    IKD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A CASE. THE BIPOLAR FOOTSWITCH WAS PROVIDING AN INTERMITTENT CONNECTION WHEN THE CABLE WAS WIGGLED. THE DOCTOR MANAGED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEGASYS BIPOLAR ACTIVE/RETURN CORD PEGASYS BIPOLAR ACTIVE/RETURN CORD IKD ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other