BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 237369 · Received August 20, 1999

    Report

    Report Number
    8010047-1999-00028
    Event Type
    Malfunction
    Date Received
    August 20, 1999
    Date of Event
    July 13, 1999
    Report Date
    July 27, 1999
    Manufacturer
    OLYMPUS OPTICAL CO., LTD
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 07/13/1999, THE PHYSICIAN WAS PERFORMING A COLONOSCOPY PROCEDURE ON A PT, BECAUSE SHE HAD COMPLAINED OF A SWOLLEN STOMACH. DURING THE PROCEDURE, THE PT BEGAN TO COMPLAIN OF DISCOMFORT IN THE ABDOMINAL AREA. THE PHYSICIAN WAS CONCERNED THAT THE LIGHT SOURCE MAY HAVE OVER INSUFFLATED THE PT DURING THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE PT WAS TAKEN TO RADIOLOGY FOR X-RAYS AND WAS FOUND TO BE OVER INSUFFLATED. THE PT BEGAN TO PASS GAS NATURALLY AND NO PT INJURY OCCURRED. THE PROCEDURE WAS PERFORMED ON AN OUTPATIENT BASIS; THE PT LEFT THE HOSP THAT DAY AND DID NOT HAVE ANY REPORTED PROBLEMS. FOLLOWING THE 07/13/1999 PROCEDURE, THE PHYSICIAN WAS PERFORMING A SIGMOIDOSCOPY ON A DIFFERENT PT; THE DATE OF THIS PROCEDURE IS UNK. DURING THIS PROCEDURE THE PHYSICIAN FELT THE UNIT INSUFFLATED THE PATIENT VERY QUICKLY. NO PT DISCOMFORT OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS UNIVERSAL LIGHT SOURCE GCT OLYMPUS OPTICAL CO., LTD CLV-U20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN