BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCON ACMI CYSTOSCOPIC INSTRUMENTATION

    MDR report key: 27978 · Received September 29, 1995

    Report

    Report Number
    27978
    Event Type
    Injury
    Date Received
    September 29, 1995
    Date of Event
    August 17, 1995
    Report Date
    August 17, 1995
    Manufacturer
    CIRCON ACMI
    Product Code
    FAJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEW INSTRUMENTATION WAS CLEANED AND STERILIZED AND EXAMINED PRIOR TO USE. PHYSICIAN NOTICED METAL FLAKES IN PTS BLADDER. PHYSICIAN USED BIOPSY FORCEPS TO REMOVE THE FLAKES. PT APPEARS TO HAVE HAD NO REVERSE REACTION. ADD'L MODEL # 190-NR, E153 022017. ADD'L CAT # E153 022017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCON ACMI CYSTOSCOPIC INSTRUMENTATION CYSTOSCOPIC INSTRUMENTATION FAJ CIRCON ACMI E121-S E154 E154 CRA E131-0

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention