BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE INTUBATION VIDEO ENDOSCOPE

    MDR report key: 5077773 · Received September 9, 2015

    Report

    Report Number
    MW5056160
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    KARL STORZ
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE KARL STORZ FLEXIBLE INTUBATION VIDEO ENDOSCOPE (PART #11302 BDX) HAS A CHANNEL THAT REQUIRES CLEANING. ACCORDING TO AAMI ST91 PRE-CLEANING SHOULD BEGIN AT THE POINT OF USE. THE IFU FOR THE KARL STORZ PRODUCT #11302BDX DOES NOT INCLUDE POINT OF USE CLEANING FOR THE CHANNEL, IT ONLY DISCUSSES CLEANING THE EXTERIOR OF THE SCOPE. NOT HAVING THE PRE-CLEANING STEP OF FLUSHING FLUIDS THROUGH THE CHANNEL CAN RESULT IN THE FORMATION OF BIO-FILM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595486 FLEXIBLE INTUBATION VIDEO ENDOSCOPE FLEXIBLE ENDOSCOPE GCQ KARL STORZ 111302BDX

    Patients

    Seq Age Sex Outcome Treatment
    1