BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 2093259 · Received April 14, 2011

    Report

    Report Number
    2242352-2011-00345
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE SCOPE. THE DEVICE HAS BEEN SENT TO THE ORIGINAL EQUIPMENT MFR FOR FURTHER TESTING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADD'L INFO IS REC'D. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THEY HAVE HAD AN ISSUE WITH 2 OF THE VH-1111 (ENDOSCOPES) OVER THE LAST 2 WEEKS. THEY HAVE BEEN CLEANING THIS EQUIPMENT THE SAME WAY SINCE THEY ACQUIRED THEM (STERRAD OR GASSING). THEY HAVE STATED THAT 2 OF THEIR SCOPES HAVE WATER DROPLETS ON THE INSIDE OF THE SCOPE AND THEY ARE UNABLE TO GET THIS OUT. AN ADDITIONAL EMAIL FROM THE HOSPITAL STATED "THERE WERE NO INCIDENTS. WE CLEANED THE SCOPES AND LOOKED IN THEM AFTER THE PROCEDURE AND THEY WERE BLURRY. WE TOOK A MAGNIFYING GLASS AND WATER DROPLETS WERE IN THE SCOPE. WE HAVE NEVER STEAM AUTOCLAVED THEM. WE HAVE GASSED AND STERRAD THEM ONLY." THE PRODUCTS WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7MM EXTENDED LENGTH ENDOSCOPE 7 MM ENDOSCOPE GCJ MAQUET CARDIOVASCULAR VH-1111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA