BEUDAMED
    FDA Adverse Event Death Summary report: N

    OYLMPUS

    MDR report key: 118250 · Received September 8, 1997

    Report

    Report Number
    8010047-1997-00024
    Event Type
    Death
    Date Received
    September 8, 1997
    Date of Event
    April 1, 1997
    Report Date
    August 27, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING THREE COLONOSCOPIES WERE PERFORMED BY THE SAME PHYSICIAN AND WERE REPORTED BY HIM TO OLYMPUS ON 8/27/97. COMPLAINT DESCRIPTION #1: DR REPORTED THAT AN 80 Y/O WOMAN WITH MULTIPLE HEALTH PROBLEMS, DIED DURING AN ATTEMPTED COLONOSCOPY IN 4/97. PT DEVELOPED SUBCUTANEOUS EMPHYSEMA IN TISSUE AROUND NECK, FACE AND ABDOMEN AND DUE TO DO NOT RESUSCITATE ORDER, ATTEMPTS AT RESUSCITATION WERE NOT MADE. COLONOSCOPY HAD BEEN ATTEMPTED SINCE PT HAD A GI BLEED AND AN UNSTABLE BLOOD COUNT. AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 2

    COMPLAINT DESCRIPTION #2: IN 6/97, THE DR ATTEMPTED A COLONOSCOPY ON A 70 Y/O WOMAN FOR POSITIVE HEMACULT. ALTHOUGH THE DR ATTEMPTED TO PASS THROUGH THE SIGMOID COLON FOR APPROX 18 MINUTES, HIS ATTEMPTS WERE UNSUCCESSFUL AND THE PROCEDURE WAS ABANDONED. FOLLOWING THE ATTEMPTED COLONOSCOPY, THE DR NOTICED THAT PT'S ABDOMEN HAD BECOME DISTENDED. AFTER FURTHER OBSERVATION, THE DR SENT HER FOR AN X-RAY WHICH REVEALED FREE ABDOMINAL AIR IN THE ABDOMEN. SHE WAS TRANSPORTED TO THE OPERATING ROOM AND THE SURGEON CONFIRMED THE FREE ABDOMINAL AIR WITH THE ABSENCE OF FLUID. NO PERFORATION IN THE SIGMOID COLON OR BOWEL WAS FOUND. HOWEVER, THE SURGEON DID OBSERVE A VERY INFLAMED CECUM AND CONCLUDED THAT THE CECUM HAD BECOME DISTENDED BY AIR PRESSURE.

    Description of Event or Problem · 3

    COMPLAINT DESCRIPTION #3: ON 8/18/97, A DIAGNOSTIC COLONSCOPY WAS PERFORMED ON A HEALTHY 69 Y/O FEMALE WITH HEMACULT POSITIVE STOOLS. IT TOOK APPROX 8-9 MINUTES TO ADVANCE TH THE CECUM, AND WHEN THE COLONSCOPE HAD REACHED THAT POINT, THE DR NOTED A RED, ECCHYMOTIC, HEMORRAHAGIC AND DISTENDED LINING. AFTER SUCCESSFULLY COMPLETING THIS DIAGNOSIS, THE DR WITHDREW THE COLONOSCOPE AND THEN REVISITED THE CECUM IN ORDER TO ASPIRATE AIR. HOWEVER, HE WAS UNSUCCESSFUL IN HIS ATTEMPT TO ASPIRATE SINCE HE WAS UNABLE TO MOVE ABOUT FREELY ONE THERE. SINCE THE DIAGNOSTIC PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED, THE SECOND ATTEMPT WAS ABANDONED. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PT WAS MONITORED AND THE DR NOTED THAT THE PT'S PULSE-OXYGEN WAS AT APPROX 82-84% WHICH WAS CONSIDERED LOW. OXYGEN WAS GIVEN, THE ABDOMEN LOOKED DISTENDED AND IN GENERAL, THE PT DID NOT LOOK WELL. THE PT WAS TRANSPORTED TO THE ADJACENT EMERGENCY ROOM WHERE SHE UNDERWENT AN X-RAY. THE X-RAY REVEALED FREE AIR IN THE ABDOMEN AND LEFT PNEUMOTHORAX. SHE NEXT DEVELOPED SUBCUTANEOUS EMPHYSEMA. IN THE EMERGENCY ROOM, THE SURGEON PLACED A TUBE IN HER CHEST IN ORDER TO INSUFFLATE HER LUNG. HAVING SUCCESSFULLY COMPLETED THIS, SHE WAS TAKEN TO THE OPERATING ROOM. DURING EVAL, THE SURGEON NOTED THAT THE PT HAD A ONE CM EAR IN THE LEFT DIAPHRAGM BUT NO ENDOSCOPY HOLES HAD BEEN FOUND IN THE COLON. ADDTIONALLY, THE CECUM LOOKED DISTENDED, WAS COLLAPSED AND THERE WAS NO AIR IN THE SMALL INTESTINE. ALTHOUGH THE COLONOSCOPE PASSED THROUGH THE LEFT COLON, THE SURGEON DESCRIBED THE LEFT COLON AS A LITTLE IRRITATED BUT WITHOUT HOLES AND ABSENT OF FLUID. THE PT WAS RELEASED AFTER A PROLONGED HOSP STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OYLMPUS LIGHT SOURCE FFS THE OLYMPUS OPTICAL CO. C;V-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death
    2 70 YR
    3 69 YR