BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST-CB1

    MDR report key: 8195282 · Received December 26, 2018

    Report

    Report Number
    8010047-2018-02562
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    December 4, 2018
    Report Date
    March 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT ONE DAY AFTER AN ENDOSCOPIC SUBMUCOSA DISSECTION (ESD) PROCEDURE ON THE ASCENDING COLON USING OLYMPUS SPLINTING TUBE MODEL ST-CB1, OLYMPUS COLONOVIDEOSCOPE MODEL PCF-H290ZL, AND PCF-H290TL, A PERFORATION WAS FOUND IN THE SIGMOID COLON OF THE PATIENT DURING A FOLLOW UP EXAMINATION FOR THE ABDOMINAL PAIN ACOMPANIED WITH A FEVER. THE USER FACILITY PERFORMED AN OPEN ABDOMINAL SURGERY AND REPAIRED THE PERFORATION. IT HAD BEEN REPORTED THAT THE ESD PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NEITHER DEVICE MALFUNCTION NOR PATIENT¿S COMPLAINT OF PAIN. OMSC SUBMITS THREE MEDICAL DEVICE REPORT ON THE THREE DEVICES THAT MAY HAVE BEEN INVOLVED IN THE PERFORATION. THIS IS THE FIRST REPORT OUT OF A TOTAL OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034259 ST-CB1 SINGLE USE SPLINTING TUBE FED OLYMPUS MEDICAL SYSTEMS CORP. ST-CB1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other