BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 2192948 · Received July 21, 2011

    Report

    Report Number
    2242352-2011-00989
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WERE NO NON-CONFORMITIES WITH THE SCOPE. THE LENS WAS ABLE TO BE LOOKED THROUGH. THE LIGHT ADAPTOR PORT LENS APPEARED DISCOLORED. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT, "SCOPE FOGGY" COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-1111 SCOPE WAS BEING HOOKED UP TO USE IN A CASE AND IT WAS DISCOVERED TO BE FOGGY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. 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