BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1979305 · Received January 19, 2011

    Report

    Report Number
    1221826-2011-00002
    Event Type
    Other
    Date Received
    January 19, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 17, 2011
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR LABELING CONTAINS THE WARNING REGARDING NOT USING CIDEX OPA ON INSTRUMENTS USED ON BLADDER CANCER PATIENTS.

    Description of Event or Problem · 1

    THE DATA AND INFO CONTAINED HEREIN IS BEING SUBMITTED TO THE FDA TO COMPLY WITH THE REGULATIONS (21 CFR PART 803) PERTAINING TO MEDICAL DEVICE REPORTING. THIS MDR IS BASED ON PRELIMINARY INFO RECEIVED BY KARL STORZ, WHO HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THE ADVERSE EVENT. ALLEGEDLY, THE DOCTOR REPORTED THAT 3-4 BLADDER CANCER PATIENTS EXPERIENCED ANAPHYLACTIC ALLERGIC REACTIONS AFTER THIS CYSTOSCOPE WAS USED. DURING FOLLOW UP CALL WITH DOCTOR, WE LEARNED THAT HE WAS USING CIDEX OPA TO REPROCESS THE SCOPE. WE EXPLAINED THAT CIDEX OPA IS CONTRAINDICATED FOR USE WHEN SCOPE IS USED ON BLADDER CANCER PATIENTS. HE CONFIRMED HE WILL NO LONGER USE CIDEX OPA. PT CONDITIONS GOOD AFTER STEROID AND BENADRYL TREATMENT. THE INFO REGARDING CONTRAINDICATION IS CONTAINED IN ASP (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CYSTOSCOPE FAJ KARL STORZ ENDOVISION 11272CU1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other