BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8010047-2017-01719

    MDR report key: 7016607 · Received November 9, 2017

    Report

    Report Number
    8010047-2017-01719
    Event Type
    Injury
    Date Received
    November 9, 2017
    Report Date
    February 22, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO CORRECT "DEVICE PRODUCT CODE."

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION OF THE SUBJECT DEVICES CONCERNING THIS CASE HAS NOT BEEN REPORTED. ALSO, SINCE THE SERIAL NUMBERS OF THESE DEVICES ARE UNKNOWN, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT CONFIRM THE MANUFACTURING HISTORY. BECAUSE THE USER FACILITY RECOGNIZED AS COMPLICATION IN THE CONCLUSION OF THE REPORT, THIS CASE IS NOT THE MALFUNCTION OF DEVICE, IT SEEMS TO BE COMPLICATION. 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 25TH (B)(6) DIGESTIVE DISEASE WEEK ((B)(6) 2017). ARTICLE TITLE: THE TREATMENT RESULTS OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN OUR HOSPITAL THE ARTICLE STUDIED ON THE TREATMENT RESULTS OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WHICH WERE TOTAL OF 162 CASES PERFORMED FROM APRIL 2010 TO FEBRUARY 2017. THE TWO TYPE OF SCOPE WERE USED IN THESE PROCEDURES: PCF-Q260JI (FROM A TRANSVERSE COLON TO A CECUM) AND GIF-Q260J (FROM A RECTUM TO A DESCENDING COLON) AND A NON OLYMPUS HIGH FREQUENCY GENERATOR (VIO300D) WAS USED IN COMBINATION WITH THEM. THE PARTS OF THE TREATED BOWEL WERE A CAECUM (24 CASES), AN ASCENDING COLON (31 CASES), A TRANSVERSE COLON (30 CASES), A DESCENDING COLON (7 CASES), SIGMOID COLON (24 CASES) AND A RECTUM (46 CASES). IN THE SUBJECT PROCEDURES, COMPLICATIONS OCCURRED AS FOLLOWS. SECONDARY HEMORRHAGE: 4 CASES (STOP THE BLEEDING IN ALL CASES). PERFORATION: 4 CASES (THE POINTS OF PERFORATION WERE SMALL, SO STOP THE BLEEDING WITH A CLIP IN ALL CASES). CANCELLED PROCEDURE BECAUSE OF MUSCULARIS EXTERNA TRACTION: 1 CASE. IN THIS SURVEY THE PERCENTAGE OF SUCCESSFUL MUCOSAL RESECTION AT ONE TIME WAS 95.6%, AND THE PERCENTAGE OF CURATIVE RESECTION WAS 97.5%. ESD PERFORMED AT THE INVESTIGATED FACILITY HAS BEEN PERFORMED RELATIVELY SAFE. THIS IS 7 OF 8 REPORTS. (SECONDARY HEMORRHAGE 4CASES AND PERFORATION IS 4 CASES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795293 FDF OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention