BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14288961 · Received May 5, 2022

    Report

    Report Number
    8010047-2022-07626
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 27, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED "APPLICATION OF ARGON PLASMA COAGULATION FOR GASTROINTESTINAL ANGIODYSPLASIA IN CHILDREN¿ EXPERIENCE FROM A TERTIARY CENTER" AN INFANT FEMALE EXPERIENCED BACTERIAL ENTEROCOLITIS AFTER A PROCEDURE USING AN OLYMPUS SCOPE. EVENTS AS FOLLOWS: 1-MONTH-17-DAY-OLD GIRL WITH FAILURE TO THRIVE (BODY HEIGHT 50¿85TH PERCENTILE, BODY WEIGHT < 3RD PERCENTILE) PRESENTED BLOOD-TINGED DIARRHEA FOR A WEEK, ACCOMPANIED BY TRANSIENT LOW-GRADE FEVER AND SKIN RASHES. SHE WAS INITIALLY ADMITTED TO A LOCAL HOSPITAL, WHERE SURVEYS FOUND NORMOCYTIC ANEMIA (HB 7.6 G/DL), POSITIVE STOOL OCCULT BLOOD (4+), AND NEGATIVE RESULTS FOR ALL STOOL BACTERIAL CULTURES. THE SEVERITY DID NOT IMPROVE WITH LACTOSE-FREE FORMULA FEEDING, ANTACID AND EMPIRIC ANTIBIOTICS. AFTER REFERRAL TO THE EMERGENCY ROOM, SHE WAS ADMITTED TO OUR ICU DUE TO IMPENDING SHOCK. LABORATORY TESTS SHOWED ANEMIA (HB 7.2 G/DL), MILDLY ELEVATED EOSINOPHIL PERCENTAGE (UP TO 10.4%, ABSOLUTE COUNT 1,050/¿L), THROMBOCYTOSIS (PLATELET 825,000/¿L), HYPOALBUMINEMIA (ALBUMIN 1.94 G/DL), NORMAL INR, AND NORMAL CRP LEVELS. THE ABDOMINAL SONOGRAPHY AND EGD WERE UNREMARKABLE. EXTENSIVELY HYDROLYZED FORMULA WAS PRESCRIBED, BUT HER BLOODY DIARRHEA PERSISTED WITH CONTINUOUS ANEMIA REQUIRING BLOOD TRANSFUSION. THEREFORE, COLONOSCOPY WAS ARRANGED USING A PEDIATRIC EGD SCOPE, WHICH REVEALED COLITIS (RECTUM TO DESCENDING COLON, THE SEGMENT REACHED BY THE SCOPE) OOZING WERE TREATED WITH APC SMOOTHLY (FIGURE 1D). COLONIC BIOPSIES SUGGESTED EOSINOPHILIC COLITIS, AND COW¿S MILK PROTEIN ALLERGIC PROCTITIS WAS CONSIDERED. THE FREQUENCY OF DIARRHEA GRADUALLY DECREASED AFTER CHANGING TO AN AMINO ACID-BASED FORMULA (ELECARE). HOWEVER, INTERMITTENT BLOODY STOOL WAS STILL NOTED. CONSIDERING THE FREQUENCY OF COLONOSCOPY AND SEDATION IN SUCH A SHORT PERIOD (TWICE IN 1 WEEK), AND INACCESSIBLE PROXIMAL COLONIC SEGMENTS, PROPRANOLOL WAS PRESCRIBED. HER BLOODY STOOL LESSENED FOLLOWING THE USE OF PROPRANOLOL (ORAL FORM, 1 MG/KG/DAY AFTER GRADUAL TITRATION) WITHOUT FURTHER NEED FOR BLOOD TRANSFUSION. SUBSEQUENT LABORATORY TESTS AFFIRMED THE CORRECTION OF ANEMIA AND HYPOALBUMINEMIA. DURING OUTPATIENT FOLLOW-UP, HER FORMULA WAS STEPWISE SHIFTED TO EXTENSIVELY HYDROLYZED FORMULA (ALFARE), WITH A DAILY STOOLING OF 1¿5 TIMES AND CONTINUOUS WEIGHT GAIN (3RD TO 10TH PERCENTILE). NO MORE GROSS HEMATOCHEZIA WAS NOTED, AND PROPRANOLOL WAS GRADUALLY TAPERED OFF. IN THE SUBSEQUENT 1.5 YEARS, SHE WAS ONLY ADMITTED ONCE FOR BACTERIAL ENTEROCOLITIS. THERE IS NO REPORT OF DEVICE MALFUNCTION REPORTED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569251 EVIS GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-XP240

    Patients

    Seq Age Sex Outcome Treatment
    1 47 DA Female Required Intervention| O