BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PJF-160

    MDR report key: 13331537 · Received January 24, 2022

    Report

    Report Number
    8010047-2022-01844
    Event Type
    Injury
    Date Received
    January 24, 2022
    Report Date
    January 24, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170433498
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CONJUGATED HYPERBILIRUBINEMIA IN INFANTS: IS THERE STILL A ROLE FOR ERCP?". THE LITERATURE REPORTED THE RESULT OF 255 PATIENTS (INFANTS AGED UP TO 1 YEAR) WITH SUSPICION OF BILIARY OBSTRUCTION WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE USING OLYMPUS PEDIATRIC DUODENOSCOPE PJF AND ANOTHER DEVICE. IN THE LITERATURE, THE FOLLOWING COMPLICATIONS HAVE BEEN REPORTED TO HAVE OCCURRED. ASYMPTOMATIC HYPERAMYLASEMIA (12.9%). SUSPICION OF PERFORATION (1 CASE). RETROPERITONEAL DEPOT OF THE CONTRAST MEDIUM (1 CASE). THE LITERATURE STATES AS FOLLOWS, "THE OVERALL COMPLICATION RATE WAS 13.7% OF ERCP PROCEDURES. ASYMPTOMATIC HYPERAMYLASEMIA OCCURRED IN 12.9%. IT IS QUESTIONABLE IF ASYMPTOMATIC HYPERAMYLASEMIA SHOULD BE INCLUDED IN THE COMPLICATION RATE. THE SUSPICION OF PERFORATION (ABDOMINAL PAIN AND ELEVATION OF CRP) OCCURRED IN ONE CHOLESTATIC INFANT WITH A CHOLEDOCHAL CYST AFTER AN UNSUCCESSFUL BILIARY STENT INSERTION. THE PROBLEM WAS RESOLVED CONSERVATIVELY WITH PARENTERAL NUTRITION AND INTRAVENOUS ANTIBIOTIC THERAPY. IN ONE CASE, A RETROPERITONEAL DEPOT OF THE CONTRAST MEDIUM EMERGED DURING THE PROCEDURE. IT WAS RESOLVED CONSERVATIVELY (PARENTERAL NUTRITION AND ANTIBIOTIC THERAPY). THERE WERE NO CASES OF ERCP-INDUCED PANCREATITIS. NO MORTALITY WAS OBSERVED AFTER ERCP." THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE IN QUESTION. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. HOWEVER, OMSC ASSUMES THAT "SUSPICION OF PERFORATION" AND "RETROPERITONEAL DEPOT OF THE CONTRAST MEDIUM" MIGHT BE RELATED TO THE SUBJECT DEVICE, AND THE SUBJECT DEVICE MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY BECAUSE THE COMPLICATIONS SUGGESTING FASTING TREATMENT AND HOSPITALIZATION WAS PROLONGED. THEREFORE, OMSC DETERMINED THAT THE COMPLICATIONS WERE ADVERSE EVENTS TO SUBMIT. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) DEPENDING ON THE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935331 PJF-160 DUODENO VIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. PJF-160 04953170433498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R