BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 285342 · Received July 10, 2000

    Report

    Report Number
    8010047-2000-00040
    Event Type
    Injury
    Date Received
    July 10, 2000
    Date of Event
    June 12, 2000
    Report Date
    June 14, 2000
    Manufacturer
    THE OLYMPUS OPTICAL CO. LTD
    Product Code
    FAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO ROUTINE FLEXIBLE SIGMOIDOSCOPY EXAMINATIONS WERE PERFORMED IN A PHYSICIANS OFFICE ON 6/2/00. FOLLOWING THE FIRST PROCEDURE THE PT WENT HOME BUT CALLED THE PHYSICIAN SOMETIME LATER COMPLAINING THAT HE/SHE WAS IN PAIN. WHEN THE PT RETURNED FOR EXAMINATION, THE PHYSICIAN NOTICED A PERFORATION OF THE SIGMOID COLON. THE PT WAS ADMITTED TO THE HOSP WHERE A TEMPORARY COLOSTOMY WAS PERFORMED. THE PHYSICIAN MENTIONED THAT THE PT WILL HAVE THE COLOSTOMY REVERSED AT A LATER DATE.

    Description of Event or Problem · 2

    A FEW HOURS AFTER THE SECOND PROCEDURE WAS COMPLETED ON 6/12/00, THE PT CALLED THE PHYSICIAN WITH COMPLAINTS OF CHILLS, FEVER AND BLEEDING. THE PHYSICIAN DID NOT PERFORM A FOLLOW-UP EXAMINATION ON THE PT - THEY RECOMMENDED THAT THE PT BE HOSPITALIZED FOR FOLLOW UP TREATMENT, IF NECESSARY. ON 6/30/00, THE PHYSICIAN STATED THAT ALTHOUGH THE PT HAD MULTIPLE SYMPTOMS, THEY WERE UNABLE TO DETERMINE WHY THE PT BECAME ILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SIGMOIDOSCOPE FAM THE OLYMPUS OPTICAL CO. LTD OSF-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention
    2 UNKNOWN Required Intervention