BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 3871281 · Received April 15, 2014

    Report

    Report Number
    2242352-2014-00424
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND NO 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 WAS CLEAR VISIBILITY THROUGH THE DISSECTION TIP, HOWEVER THE ILLUMINATION INTENSITY AT THE DISTAL END WAS NOT AS BRIGHT AS A REFERENCE DEVICE. IT APPEARS AS THOUGH SOME OF THE SHAFTS INTERNAL LIGHT FIBERS WERE DAMAGED. BASED UPON THE EVAL RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THERE WAS A BLACK SPOT IN THE BOM 7MM EXTENDED LENGTH ENDOSCOPE AND THE FIBER OPTICS LOOK DAMAGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230543 BOM 7MM EXTENDED LENGTH ENDOSCOPE ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR, LLC VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR