BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 2152362 · Received June 24, 2011

    Report

    Report Number
    2242352-2011-00691
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE SCOPE LENS APPEARED CLOUDY. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "SCOPE CLOUDY" WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE VASOVIEW 7MM ENDOSCOPE LENS DID NOT WORK. IT WAS LOOKED AT AND IT WAS EXTREMELY CLOUDY AND UNABLE TO SEE ANYTHING THROUGH THIS. THE ACCOUNT DOES NOT KNOW IF IT WAS BEFORE A PROCEDURE, BUT ASSUMES THAT THEY WENT TO USE IT AND WERE UNABLE TO DO SO. NO OTHER INFORMATION WAS AVAILABLE. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7MM EXTENDED LENGTH ENDOSCOPE 7 MM ENDOSCOPE GCJ MAQUET CARDIOVASCULAR VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA