BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 3101411 · Received May 3, 2013

    Report

    Report Number
    2242352-2013-00416
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CAMERA CORD ATTACHMENT ON THE 7 MM EXTENDED LENGTH ENDOSCOPE BROKE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195484 7 MM EXTENDED LENGTH ENDOSCOPE ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR, LLC VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA