BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 1553727 · Received November 25, 2009

    Report

    Report Number
    9610773-2009-00019
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    August 19, 2009
    Report Date
    August 19, 2009
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE DEVICE WAS REPORTEDLY SENT TO A THIRD-PARTY SERVICE PROVIDER FOLLOWING THE EVENT. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENTS AND WAS INFORMED THAT THE PHYSICIAN BELIEVED THAT THE PT WAS HYPERSENSITIVE TO THE CIDEX OPA REPROCESSING AGENT USED TO DISINFECT THE SCOPE. THE PHYSICIAN STATED THAT HE DID NOT SUSPECT THE SCOPE TO BE THE CAUSE OF THE PT'S EXPERIENCE. THE PHYSICIAN REPORTED USING THE SAME MODEL OF DEVICE ON THIS PT AT A DIFFERENT FACILITY WITH NO COMPLICATIONS. THE CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IMPROPER REPROCESSING OF THE CYSTOSCOPE AND/OR THIRD PARTY REPAIRS CANNOT BE RULED OUT AS CONTRIBUTORY FACTORS. IF SIGNIFICANT INFO BECOMES AVAILABLE LATER, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. SEE ALSO MFR# 9610773-2009-00018 FOR A RELATED REPORT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PT DEVELOPED ALLERGIC REACTIONS WITH LOCALIZED INFLAMMATION DURING CYSTOSCOPY PROCEDURES ON TWO SEPARATE OCCASIONS. THE PHYSICIAN REPORTED THAT THE PT'S GLANS PENIS BECAME INFLAMED DURING THE PROCEDURES. THE PROCEDURES WERE COMPLETED USING THE SAME DEVICE. THE PT WAS PROVIDED BENADRYL AND WAS RELEASED FROM THE PHYSICIAN'S CLINIC THE SAME DAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE FAJ OLYMPUS WINTER & IBE GMBH CYF-V2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1