BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 276464 · Received May 3, 2000

    Report

    Report Number
    8010047-2000-00022
    Event Type
    Death
    Date Received
    May 3, 2000
    Report Date
    April 4, 2000
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A PT EXPIRED THE FOLLOWING DAY AFTER UNDERGOING A COLONOSCOPY PROCEDURE. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS INTESTINAL INFARCTION. BACKGROUND: THE PHYSICIAN PROVIDED THE FOLLOWING INFO REGARDING THE COLONOSCOPY AND SUBSEQUENT PT DEATH. M.D. STATED THAT THE PT HAD AN INITIAL COLONOSCOPY PROCEDURE APPROX FIVE TO SIX DAYS BEFORE A SECOND COLONOSCOPY. THE FIRST COLONOSCOPY WAS PERFORMED BY A DIFFERENT DR. ACCORDING TO THE PHYSICIAN, THE DR STATED THAT THE RESULTS OF THE FIRST COLONOSCOPY INDICATED THAT THE PT ALLEGEDLY HAD COLON CANCER. THE DAY AFTER THE FIRST COLONOSCOPY, THE PT HAD ABDOMINAL SURGERY DUE TO THE ALLEGED FINDINGS (OF CANCER). FOLLOWING THE RIGHT HEMI COLECTOMY PROCEDURE, ONE OF THE MD'S NOTICED THAT THE PT'S ABDOMEN WAS DISTENDED. FIVE TO SIX DAYS AFTER THE FIRST COLONOSCOPY, THE PT HAD A SECOND COLONOSCOPY. THE PROCEDURE WAS PERFORMED BY THE PHYSICIAN. DURING THE SECOND COLONOSCOPY, PERFORATION OF THE COLON WAS NOTED, AS WELL AS ADDITIONAL ABDOMINAL DISTENTION. SINCE THE PT WAS STILL IN THE OPERATING ROOM, THE PHYSICIAN PERFORMED AN EMERGENCY LAPAROTOMY PROCEDURE FOR REPAIR OF THE PERFORATION. THE PT WAS SUBSEQUENTLY MOVED TO THE INTENSIVE CARE UNIT. ACCORDING TO THE PHYSICIAN, THE PT LOOKED WORSE THE FOLLOWING DAY. AFTER MD NOTICED THE PT'S DETERIORATING CONDITION, THE PHYSICIAN ORDERED AN ARTERIOGRAM OF ALL BLOOD VESSELS FLOWING TO THE BOWEL. MD STATED THAT THE ARTERIOGRAM INDICATED THAT ALL BLOOD VESSELS WERE TOTALLY OCCLUDED. THIS CONDITION RESULTED IN INTESTINAL INFARCTION, OR "DEAD BOWEL". THE PHYSICIAN DOES NOT KNOW WHY FLOW TO THE KIDNEYS WAS WIDE OPEN, EVEN THOUGH FLOW TO THE BOWELS HAD BEEN TOTALLY OCCLUDED. THE PT EXPIRED THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO COLONOSCOPE KOG OLYMPUS OPTICAL CO. LTD. CF-100TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death