BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOMATIC ENDOSCOPIC REPORCESSOR (AER)

    MDR report key: 576143 · Received February 25, 2005

    Report

    Report Number
    2084725-2005-00103
    Event Type
    Other
    Date Received
    February 25, 2005
    Date of Event
    December 6, 2004
    Report Date
    January 17, 2005
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT FROM USER FACILITY INDICATED THAT A PATIENT EXPERIENCED BLOOD IN THE STOOL, CRAMPS AND NAUSEA. THESE SYMPTOMS BEGAN THE FIRST POST-OP EVENING, LASTING 2 DAYS, FOLLOWING PROCESSING OF ENDOSCOPE IN AER. IT WAS REPORTED THAT THERE WERE `COLON AND BOWEL ULCERS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATIC ENDOSCOPIC REPORCESSOR (AER) AUTOMATIC ENDOSCOPE KOG ADVANCED STERILIZATION PRODUCTS 20301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other