BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPE POSITION DETECTING UNIT

    MDR report key: 6950696 · Received October 16, 2017

    Report

    Report Number
    8010047-2017-01475
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 15, 2017
    Report Date
    March 25, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PGU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REFERENCED UPD-3 WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION, THEREFORE OMSC CANNOT EVALUATE THE UPD-3. THE EXACT CAUSE OF THIS PHENOMENON CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS THE POSSIBILITY OF THIS PHENOMENON IS ATTRIBUTED TO INAPPROPRIATE HANDLING OF THE UPD-3 BY THE FACILITY. OMSC CHECKED THE MANUFACTURE HISTORY OF THE UPD-3, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE COLONOSCOPY, WHEN THE RECEIVER DISH ARM OF THE UPD-3 WAS MOVED, THE PATIENT SUFFERED THE SKIN TEAR BECAUSE THE CABLE HOLDER ON THE RECEIVER DISH STAND CONTACTED WITH THE PATIENT. THE PATIENT WAS TREATED AND BANDAGED. THE COLONOSCOPY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731493 ENDOSCOPE POSITION DETECTING UNIT ENDOSCOPE POSITION DETECTING UNIT PGU OLYMPUS MEDICAL SYSTEMS CORP. UPD-3

    Patients

    Seq Age Sex Outcome Treatment
    1