BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7581056 · Received June 8, 2018

    Report

    Report Number
    8010047-2018-01096
    Event Type
    Injury
    Date Received
    June 8, 2018
    Report Date
    June 28, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. ON JUNE 1ST, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿STUDY ON BILE DUCT STONE TREATMENT USING SHORT-SBE (SINGLE BALLOON ENDOSCOPE) FOR PATIENTS WHO EXPERIENCED INTESTINAL RECONSTRUCTIVE SURGERY¿ THAT WAS MADE IN PUBLIC IN THE 97TH CONGRESS OF THE (B)(4) GASTROENTEROLOGICAL ENDOSCOPY SOCIETY. THE LITERATURE REPORTED THE RESULT OF THE 128 PROCEDURES OF STONE TREATMENTS WHICH WERE CONDUCTED BETWEEN JULY 2013 AND OCTOBER 2018 AT THE USER FACILITY. IN THE 128 PROCEDURES, OLYMPUS SMALL INTESTINAL VIDEOSCOPES (SIF-Y0004, SIF-Y0015, SIF-H290S) WERE USED. THE LITERATURE REPORTED FOLLOWING 13 CASES OF ACCIDENTAL SYMPTOMS OCCURRED IN THE PROCEDURES. PANCREATITIS IN 7 CASES. CHOLANGITIS IN 4 CASES. PERFORATION IN 2 CASES (IN BOTH CASES, THE MEMBRANA MUCOSA WAS TORN WITH THE ENDOSCOPE. THE TORN AREA WAS CLIPPED WITH THE CLIP AND TREATED CONSERVATIVELY.) OMSC REVIEWED THE COMPLAINT RECORD ON THE USER FACILITY AND CONFIRMED THAT OMSC RECEIVED ANOTHER LITERATURE FOR THE SAME STUDY TITLED ¿STUDY ON BILE DUCT STONE TREATMENT USING SHORT-SBE (SINGLE BALLOON ENDOSCOPE) FOR PATIENTS WHO EXPERIENCED INTESTINAL RECONSTRUCTIVE SURGERY¿ THAT WAS MADE IN PUBLIC IN THE 95TH CONGRESS OF THE (B)(4) GASTROENTEROLOGICAL ENDOSCOPY SOCIETY. THE LITERATURE RECEIVED IN 2018 REPORTED THE RESULT OF THE 104 PROCEDURES OF STONE TREATMENTS WHICH WERE CONDUCTED BETWEEN JULY 2013 AND OCTOBER 2017 AT THE USER FACILITY. IN THE 104 PROCEDURES, OLYMPUS SMALL INTESTINAL VIDEOSCOPES (SIF-Y0004, SIF-Y0015, SIF-H290S) WERE USED. THE LITERATURE REPORTED FOLLOWING 14 CASES OF ACCIDENTAL SYMPTOMS OCCURRED IN THE PROCEDURES. PANCREATITIS IN 7 CASES. CHOLANGITIS IN 4 CASES. PERFORATION IN 3 CASES. OLYMPUS ALREADY SUBMIT 14 MEDICAL DEVICE REPORTS ON THE 14 ACCIDENTAL SYMPTOMS BASED ON THE LITERATURE RECEIVED IN 2018 AS FOLLOWS; 8010047-2017-01619, 8010047-2017-01597, 8010047-2017-01594, 8010047-2017-01598, 8010047-2017-01599, 8010047-2017-01600, 8010047-2017-01601, 8010047-2017-01602, 8010047-2017-01603, 8010047-2017-01604, 8010047-2017-01605, 8010047-2017-01606, 8010047-2018-01095, 8010047-2018-01096 THE REASON WHY THE TOTAL NUMBER OF ACCIDENTAL SYMPTOMS REPORTED IN THE NEWER LITERATURE REDUCED IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON MAY 11, 2018, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿STUDY ON BILE DUCT STONE TREATMENT USING SHORT-SBE (SINGLE BALLOON ENDOSCOPE) FOR PATIENTS WHO EXPERIENCED INTESTINAL RECONSTRUCTIVE SURGERY¿. THE LITERATURE REPORTED THE RESULT OF THE 104 PROCEDURES OF STONE TREATMENTS WHICH WERE CONDUCTED BETWEEN JULY 2013 AND OCTOBER 2017 AT THE USER FACILITY. IN THE 104 PROCEDURES, OLYMPUS SMALL INTESTINAL VIDEOSCOPES ( SIF-Y0004, SIF-Y0015, SIF-H290S ) WERE USED. THE LITERATURE REPORTED FOLLOWING 14 CASE OF ACCIDENTAL SYMPTOMS OCCURRED IN THE PROCEDURES. PANCREATITIS IN 7 CASES. CHOLANGITIS IN 4 CASES. PERFORATION IN 3 CASES. OMSC REVIEWED THE COMPLAINT RECORD ON THE USER FACILITY AND CONFIRMED THAT OLYMPUS ALREADY SUBMIT 12 MEDICAL REPORTS ON THE 12 OF 14 ACCIDENTAL SYMPTOMS AS FOLLOWS; 8010047-2017-01619, 8010047-2017-01597, 8010047-2017-01594, 8010047-2017-01598, 8010047-2017-01599, 8010047-2017-01600, 8010047-2017-01601, 8010047-2017-01602, 8010047-2017-01603, 8010047-2017-01604, 8010047-2017-01605, 8010047-2017-01606 SINCE THERE WAS NO INFORMATION ON THE MODEL OF THE SMALL INTESTINAL VIDEOSCOPES THAT WAS USED IN THE PROCEDURES, OMSC IS SUBMITTING MDRS ACCORDING TO THE TWO ADDITIONAL ACCIDENTAL SYMPTOMS CASES (PANCREATITIS IN 1CASES, PERFORATION IN 1 CASES). THIS IS TWO OF TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426022 UNKNOWN SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other