BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7 MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 3133522 · Received May 24, 2013

    Report

    Report Number
    2242352-2013-00496
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE, IT SHOWED NO SIGNS OF USAGE OR EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON-CONFORMITIES. A LIGHT CABLE WAS ATTACHED TO THE ILLUMINATION PORT ON THE ENDOSCOPE AND VIEWED ON A MONITOR; THERE WERE SCRATCHES OBSERVED ON THE LENS LIKELY ATTRIBUTABLE TO THE CLOUDY APPEARANCE ON THE MONITOR. BASED UPON THE EVAL RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. PRIOR TO EACH USE, "INSPECT THE ENDOSCOPE FOR VISIBLE DAMGE (E.G., CRACKS, LOOSE COMPONENTS); IF FOUND, REMOVE THE ENDOSCOPE FROM OPERATION." PLEASE SEE STEP 6 ON PAGE 4 FOR RELEVANT INFO. THE CUSTOMER HAS BEEN ADVISED OF OUR EVAL RESULTS, INCLUDING THE RELEVANT SECTION OF THE IFU. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE IMAGE WAS CLOUDY ON THE 7 MM EXTENDED LENGTH ENDOSCOPE. ANOTHER SCOPE WAS UNAVAILABLE, THEREFORE, THEY CONVERTED THE PROCEDURE AND OPENED THE PT'S LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232158 7 MM EXTENDED LENGTH ENDOSCOPE ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR, LLC VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other