BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 2210564 · Received August 8, 2011

    Report

    Report Number
    2242352-2011-01083
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MAQUWT CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE EVAL IS COMPLETE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING TRAINING FOR AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE ENDOSCOPE IMAGE WAS CLOUDY. THIS WAS FROM THE REPORTER'S TRUNK STOCK. NO HOSPITAL OR PROCEDURE INVOLVEMENT. ANOTHER SCOPE WAS USED TO FINISH THE PROCEDURE. THE EVENT OCCURRED SOMETIME FROM (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7 MM EXTENDED LENGTH ENDOSCOPE SCOPE GCJ MAQUWT CARDIOVASCULAR, LLC VH-1111 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI