BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 13188435 · Received January 7, 2022

    Report

    Report Number
    8010047-2022-01036
    Event Type
    Death
    Date Received
    January 7, 2022
    Report Date
    January 7, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 0

    ON DECEMBER 14, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "IS A COAXIAL PLASTIC STENT WITHIN A LUMEN-APPOSING METAL STENT USEFUL FOR THE MANAGEMENT OF DISTAL MALIGNANT BILIARY OBSTRUCTION?". THE PURPOSE OF THIS LITERATURE WAS TO DETERMINE WHETHER A COAXIAL DOUBLE-PIGTAIL PLASTIC STENT (DPS) WITHIN BILIARY LUMEN-APPOSING METAL STENTS (LAMS) OFFERS HAS A POTENTIAL BENEFIT IN EUS-GUIDED CHOLEDOCHODUODENOSTOMY (CDS). TWO STRATEGIES WERE COMPARED: LAMS WITH AND WITHOUT A COAXIAL DPS, IN A COHORT OF CASES WITH MALIGNANT COMMON BILE DUCT OBSTRUCTION IN WHICH ERCP HAD FAILED. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; THE STUDY COMPRISED 41 CONSECUTIVE PATIENTS (MEDIAN 72.3 AGE, 12.4 SD; 57% FEMALES) WITH MALIGNANT DISTAL BILIARY OBSTRUCTION AND FAILED ERCP (13 DUODENAL STENOSIS, 28 FAILED CANNULATION) WHO UNDERWENT EUS-CDS USING LAMS. A LINEAR ARRAY ECHOENDOSCOPE (FUJIFILM EG-580UT OR OLYMPUS GF-UCT180) WAS USED FOR EUS-CDS PROCEDURES, IN AN INTERVENTIONAL ROOM EQUIPPED WITH FLUOROSCOPY. WHEN A DIAGNOSTIC SAMPLE WAS NEEDED, A EUS-GUIDED FINE NEEDLE ASPIRATION WAS PERFORMED BEFORE OR AFTER THE TRANSMURAL DRAINAGE, AT THE ENDOSCOPIST¿S DISCRETION. FOLLOWS COMPLICATIONS WERE REPORTED. DUODENAL PERFORATION (1), HAEMORRHAGE (1), SEPSIS / POLYMICROBIAL PERITONITIS (2), PERITONEAL MIGRATION LAMS (1), RECURRENT BILIARY OBSTRUCTION (7), TECHNICAL FAILURE (2). NO INTRA-PROCEDURE AES WERE REPORTED. ALL AES APPEARED IN THE POSTPROCEDURE OR LATE PERIOD. THERE WERE 5 PROCEDURE-RELATED AES (12.8%), AND PROCEDURE-RELATED MORTALITY WAS DETECTED IN 4 CASES (9.7%). IMMEDIATE AE OCCURRED IN 2 PATIENTS (2/39): ONE PERFORATION AND ONE BLEEDING TREATED WITH CONSERVATIVE MANAGEMENT DUE TO THE PATIENT¿S POOR GENERAL CONDITION. BOTH CASES DIED, ONE AT 6 DAYS AND THE OTHER AT 1 DAY AFTER THE PROCEDURE. EARLY AE OCCURRED IN 3 PATIENTS (3/39): TWO SEVERE CHOLANGITIS WITH FATAL EVOLUTION, RECEIVING PALLIATIVE CARE UNTIL DEATH (2 AND 6 DAYS AFTER THE PROCEDURE) DUE TO THE POOR PATIENT CONDITION, AND THE OTHER A LAMS MIGRATION AFTER 3 DAYS, PALLIATIVELY TREATED WITH PERCUTANEOUS GALLBLADDER DRAINAGE. BASED ON THE AVAILABLE INFORMATION, REPORTED THESE COMPLICATIONS WERE NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE OLYMPUS PRODUCTS. HOWEVER, OMSC ASSUMES THAT THE DUODENAL PERFORATION, HEMORRHAGE, AND SEPSIS/POLYMICROBIAL PERITONITIS MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR THE PROCEDURE. WHEREAS, OMSC ASSUMES THAT THE RECURRENT BILIARY OBSTRUCTION AND TECHNICAL FAILURE WERE NOT RELATED TO THE SUBJECT DEVICE. OMSC ASSUMES THAT THE DUODENAL PERFORATION, HEMORRHAGE, AND SEPSIS/POLYMICROBIAL PERITONITIS WERE SERIOUS INJURIES SINCE THESE COMPLICATIONS MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. IN THIS LITERATURE, IT WAS REPORTED THAT THESE PATIENTS' GENERAL CONDITIONS WERE POOR. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE WAS NOT PROVIDED. AND IT WAS NOT REPORTED WHICH DEVICE WAS USED TO SUBJECT PROCEDURE. HOWEVER, OMSC ASSUMES THAT THE DUODENAL PERFORATION, HEMORRHAGE, AND SEPSIS/POLYMICROBIAL PERITONITIS WERE ADVERSE EVENTS TO SUBMIT A MEDICAL DEVICE REPORT (MDR) AS ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853568 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

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