BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VC10 PUMP, 115V

    MDR report key: 8092142 · Received November 20, 2018

    Report

    Report Number
    2951238-2018-00715
    Event Type
    Injury
    Date Received
    November 20, 2018
    Report Date
    November 20, 2018
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    HHI
    PMA / PMN Number
    K030935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. THE VC-10 INSTRUCTION MANUAL WARNS USERS "DO NOT APPLY EXCESSIVE FORCE WHILE USING THE CANNULAS AND F-SETS. EXCESSIVE PUSHING, BENDING, OR PULLING COULD RESULT IN INJURY TO THE PATIENT AND/OR BREAKAGE OF THE DEVICE." AS PART OF OR INVESTIGATION, OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THE REPORTED EVENT AND LIMITED INFORMATION WAS PROVIDED. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS COMPLAINT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED COMPLAINT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY PERFORMED 21 DILATION AND CURETTAGE (D&C) PROCEDURES BETWEEN (B)(6) 2017 TO PRESENT. OF THAT, FOUR PATIENTS DEVELOPED INTRAUTERINE HEMATOMAS AND PRESENTED TO THE EMERGENCY ROOM FOR TREATMENT. IN ADDITION, PATIENT 1 AND PATIENT 2 EXPERIENCED HEAVY BLEEDING, PATIENT 3 EXPERIENCED PAIN WITH CRAMPING AND PATIENT 4 DEVELOPED A HEMATOMETRIUM. ALL FOUR PATIENTS WERE MANAGED UNDER OUTPATIENT CARE. THIS IS 2 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931074 VC10 PUMP, 115V VC10 PUMP HHI GYRUS ACMI, INC VC-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention