BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 7012518 · Received November 9, 2017

    Report

    Report Number
    8010047-2017-01697
    Event Type
    Injury
    Date Received
    November 9, 2017
    Report Date
    November 9, 2017
    Manufacturer
    UNKNOWN
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS 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 (B)(6) 2017, OLYMPUS MEDICAL SYSTEMS CORP (OMSC) RECEIVED A LITERATURE TITLED ¿TREATMENT EFFICACY OF SHORT-TYPE SINGLE-BALLOON ENDOSCOPY (S-SBE) USING FOR PATIENTS WHO EXPERIENCED INTESTINAL RECONSTRUCTIVE SURGERY IN ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERCP)¿ THAT WAS MADE IN PUBLIC IN JAPAN DIGESTIVE DISEASE WEEK (JDDW) ON OCTOBER 2017. THE LITERATURE REPORTED THE RESULT OF 74 CASES; 144 PROCEDURES (BEFORE S-SBE INTRODUCTION: 119 PROCEDURES, AFTER S-SBE INTRODUCTION: 25 PROCEDURES) BETWEEN JANUARY 2013 AND FEBRUARY 2017. IN THE SUBJECT PROCEDURES, FOLLOWING COMPLICATIONS REPORTEDLY OCCURRED. - BEFORE S-SBE INTRODUCTION: PERFORATION OCCURRED IN 2 PROCEDURES, AND PANCREATITIS OCCURRED IN 6 PROCEDURES - AFTER S-SBE INTRODUCTION: PERFORATION OCCURRED IN 0 PROCEDURE, PANCREATITIS OCCURRED IN 3 PROCEDURES. THE LITERATURE CONCLUDED THAT, S-SBE WAS CONSIDERED TO BE USEFUL BECAUSE IT ENABLES TO PERFORM A SAFE AND WIDE-RANGING TREATMENT IN ERCP FOR PATIENTS WHO EXPERIENCED INTESTINAL RECONSTRUCTIVE SURGERY. THE PRESENTER OF THE LITERATURE STATED THAT OLYMPUS ENDOSCOPE MODEL SIF-H290S, SIF-Q260, GIF-XQ260, GIF-2T240 AND GIF-XQ260J WERE USED FOR THE PROCEDURES (OMSC REVIEWED THE SALES HISTORY RECORD AND CONFIRMED THAT THE FACILITY DID NOT PURCHASED THE GIF-XQ260J BUT GIF-Q260J). OLYMPUS IS SUBMITTING MDR ACCORDING TO THE NUMBER OF COMPLICATION CASE BECAUSE IT WAS NOT INFORMED WHICH ENDOSCOPE MODEL WAS USED IN THE PROCEDURES. THIS IS 6 OF 11 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792430 UNKNOWN UNKNOWN FDS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other