BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8010047-2017-01605

    MDR report key: 6989718 · Received October 31, 2017

    Report

    Report Number
    8010047-2017-01605
    Event Type
    Injury
    Date Received
    October 31, 2017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. ALSO, SINCE THE SERIAL NUMBER OF THIS DEVICE IS UNKNOWN, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT CONFIRM THE MANUFACTURING HISTORY. BECAUSE THE USER FACILITY RECOGNIZED AS ACCIDENTAL SYMPTOM IN THE CONCLUSION OF THE REPORT, THIS CASE IS NOT THE MALFUNCTION OF DEVICE, IT SEEMS TO BE ACCIDENTAL SYMPTOM. BUT THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REPORTED AT THE (B)(6). ARTICLE TITLE: THE STUDY OF ENDOSCOPIC BILE DUCT CALCULUS TREATMENT USING SHORT-SBE FOR POSTOPERATIVE RECONSTRUCTED INTESTINAL TRACT CASES. REPORT SUMMARY: THE ARTICLE STATED THAT STUDIED THE CLINICAL USEFULNESS OF ENDOSCOPIC BILE DUCT CALCULUS TREATMENT USING SHORT SINGLE BALLOON ENDOSCOPE (SHORT-SBE) FOR POSTOPERATIVE RECONSTRUCTED INTESTINAL TRACT CASES. THE TARGET OF THIS REPORT ARE PROCEDURES OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP)-RELATED PROCEDURES USING SHORT-SBE (PRODUCTS: SIF-Y0004, SIF-Y 0015, SIF-H290S) FROM JULY 2013 TO FEBRUARY 2017, AND CALCULUS TREATMENT PROCEDURES USING DUODENOSCOPE(JF GROUP) DURING THE SAME PERIOD. IN THE SUBJECT PROCEDURES, ACCIDENTAL SYMPTOMS OCCURRED AS FOLLOWS. SHORT-SBE GROUP: PANCREATITIS 6 CASES, CHOLANGITIS 4 CASES, PERFORATION 2 CASES JF GROUP: ACCIDENTAL SYMPTOMS(DETAILS ARE UNKNOWN) 12 CASES. CONCLUSION: ACCIDENTAL SYMPTOMS OF TREATMENT OF BILE DUCT CALCULUS USING SHORT-SBE IN THE POSTOPERATIVE RECONSTRUCTED INTESTINAL TRACT WAS WITHIN ACCEPTABLE RANGE, AND IT WAS ABLE TO CARRY OUT SAFELY IN THE SAME WAY AS USUAL TREATMENT OF BILE DUCT CALCULUS USING DUODENOSCOPE. THIS IS 11 OF 24 REPORTS. (SHORT-SBE GROUP: PERFORATION 1 OF 2 REPORTS.)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other