BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT 7 MM DISSECTION ENDOSCOPE

    MDR report key: 1063677 · Received June 20, 2008

    Report

    Report Number
    2953148-2008-00622
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE SCOPE WAS SHIPPED TO SCHOLLY FIBEROPTICS FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE RECEIVED FROM SCHOLLY FIBEROPTICS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT WHEN TESTING THE SCOPE BEFORE THE PROCEDURE, THE SCOPE IMAGE WAS CLOUDY. A REPLACEMENT SCOPE WAS TESTED AND WAS USED FOR THE CASE. THE PROCEDURE WAS COMPLETED AND THE HOSPITAL DID NOT REPORT ANY PT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 7 MM DISSECTION ENDOSCOPE GCJ GUIDANT CARDIAC SURGERY VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA