BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 14346431 · Received May 10, 2022

    Report

    Report Number
    8010047-2022-07966
    Event Type
    Death
    Date Received
    May 10, 2022
    Date of Event
    January 15, 2022
    Report Date
    August 2, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170229459
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    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

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SAFETY AND EFFICACY OF EARLY ENDOTHERAPY IN MANAGEMENT OF PANCREATIC ASCITES: WESTERN INDIAN EXPERIENCE". LITERATURE SUMMARY: THIS STUDY AIMED TO STUDY THE TIMINGS, SAFETY, AND EFFICACY OF THERAPEUTIC APPROACHES IN ITS MANAGEMENT AND THE OUTCOMES. OF THE 125 PATIENTS SCREENED, 70 (MALE, 81.4%) WERE INCLUDED. DISRUPTION IN THE PANCREATIC DUCT (PD) WAS SEEN IN 51.4% OF PATIENTS ON MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY (MRCP) AND 73.3% OF PATIENTS ON ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PD IN THE BODY REGION (46.7%) WAS THE MOST FREQUENT SITE OF DISRUPTION. EARLY ENDOTHERAPY INCLUDED A STENT BRIDGING THE DISRUPTION SITE IN 63.3% OF PATIENTS AND SPHINCTEROTOMY IN 76.7% OF PATIENTS WITH A MEDIAN TIME TO ERCP FROM SYMPTOM ONSET BEING 8.5 DAYS. THE SUCCESS RATE IN EARLY ENDOTHERAPY WAS 81.7%, WHILE THE RECURRENCE RATE WAS 8%. FOR CONSERVATIVE THERAPY ONLY, THE SUCCESS RATE WAS 60% WITH RECURRENCE IN TWO-THIRDS. THE VARIABLES CRUCIAL IN THE SUCCESS OF ENDOTHERAPY WERE A PARTIAL DISRUPTION (P<0.001), DUCTAL DISRUPTION SITE (P=0.004), SPHINCTEROTOMY (P=0.013), AND A BRIDGING STENT (P=0.001). SIGNIFICANT PANCREATIC NECROSIS (P<0.001) AND INTRADUCTAL CALCULI (P=0.002) WERE THE FACTORS RESPONSIBLE FOR FAILURE IN ENDOTHERAPY. EARLY ENDOTHERAPY IS SAFE AND EFFECTIVE IN THE TREATMENT OF PANCREATIC ASCITES. THE EFFICACY OF ENDOTHERAPY IS AUGMENTED BY PD STENTING COMBINED WITH PANCREATIC SPHINCTEROTOMY AND A BRIDGING STENT. EARLY ENDOTHERAPY FAILED IN 11/60 (18.3%) PATIENTS (5 WITH ANP AND 6 WITH CP) AT 6 WEEKS, DUE TO INTRADUCTAL CALCULI. A REPEAT ERCP WITH PANCREATIC DUCT STENTING WITH A LONGER STENT WAS DONE IN 10 OF THESE PATIENTS WHO RESPONDED WHILE 1 PATIENT WHO HAD UNDERGONE DEN DIED BEFORE BEING REFERRED FOR SURGERY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: EARLY ENDOTHERAPY FAILURE - (10). EARLY ENDOTHERAPY FAILURE & DEATH - (1). THIS ARTICLE INCLUDES 2 REPORTS: PATIENT IDENTIFIER (B)(6) IS FOR THE ENDOTHERAPY FAILURE. PATIENT IDENTIFIER (B)(6) IS FOR THE PATIENT WITH ENDOTHERAPY FAILURE WHO DIED. THIS IS REPORT 2 OF 2 FOR PATIENT IDENTIFIER (B)(6) FOR THE PATIENT WITH ENDOTHERAPY FAILURE WHO DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068991 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-150 04953170229459

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| D| R