BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOSCOPE

    MDR report key: 3906270 · Received June 26, 2014

    Report

    Report Number
    MW5036932
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STORZ
    Product Code
    FBO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MD WAS DOING A CYSTOSCOPY PROCEDURE USING A 9.5 FRENCH PEDIATRIC CYSTOSCOPE. HE PLACED A 0.035 INCH WIRE UP THE URETER WITHOUT DIFFICULTY UNDER FLUOROSCOPY. HE THEN TRIED TO PASS A 5-FRENCH CATHETER OVER THE WIRE BUT IT WOULD NOT EASILY GO THROUGH THE SCOPE. HE THEN PASSED A 4-FRENCH CATHETER OVER THE WIRE BUT IT MET RESISTANCE AND IT ACTUALLY SHAVED A PIECE OF PLASTIC OR SILICONE OFF THE OUTSIDE PART OF THE CATHETER. APPARENTLY, THERE WAS A SHARP EDGE ON THE INSIDE OF THE SCOPE THAT SHAVED THE CATHETER. THE MD REMOVED THE SCOPE AND GOT A NEW SCOPE AND PASSED A 0.025 INCH WIRE ALONG THE OTHER WIRE UP THE URETER WITHOUT DIFFICULTY AND REMOVED THE LARGER WIRE. THE MD CONCLUDED HIS INTENDED PROCEDURE. HE TRIED TO REMOVE THE SHAVED PIECE OF SILICONE THAT WAS IN THE BLADDER WITH THE GRASPING FORCEPS BUT COULD NOT GET IT OUT BECAUSE IT WAS FLOATING AT THE VERY TOP OF THE BLADDER AND IT APPEARED TO BE QUITE SMALL AND THE MD WAS CERTAIN THAT THE PT WOULD VOID THIS OUT ONCE THE FOLEY WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374473 CYSTOSCOPE PEDIATRIC CYSTOSCOPE FBO STORZ 9.5 CYSTOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other