BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 3063663 · Received April 12, 2013

    Report

    Report Number
    2242352-2013-00357
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE ENDOSCOPE LENS WAS CLOUDY AND THEY WERE UNABLE TO SEE A CLEAR DISPLAY. THE HOSPITAL NOTED THAT THERE WAS A FILM OVER THE LENS THAT COULD NOT BE REMOVED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159436 7 MM EXTENDED LENGTH ENDOSCOPE ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR, LLC VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA