BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLER BAR (6/PK)

    MDR report key: 4918854 · Received July 16, 2015

    Report

    Report Number
    2951238-2015-00315
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 19, 2015
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    FAS
    PMA / PMN Number
    K890328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY THAT THE DEVICE REFERENCED IN THE REPORT WAS DISCARDED AFTER USE IN THE PROCEDURE. THEREFORE, NO DEVICE WILL BE RETURNED TO OLYMPUS FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC ENDOMETRIAL ABLATION PROCEDURE FOR UTERINE BLEEDING, THE PATIENT SUSTAINED A BURN INSIDE THEIR CERVIX AND VAGINA UPON WITHDRAWAL OF THE INSTRUMENT FROM THE UTERUS. THE PATIENT WAS PROVIDED MEDICATION TO TREAT THE BURN, HELP MANAGE THE PAIN AND THE SYMPTOMS. IT WAS STATED THAT THERE WAS NO BLEEDING OBSERVED AT THE BURN SITE. THE PATIENT WILL BE SCHEDULED FOR A FOLLOW UP WITH THE PHYSICIAN AT A LATER DATE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE DEVICE WAS INSPECTED AFTER THE PROCEDURE AND IT APPEARED THAT THE INSULATION ON THE EXTERIOR PORTION OF THE LOOP WAS PEELING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463053 ROLLER BAR (6/PK) ROLLER BAR (6/PK) FAS GYRUS ACMI INC. RB\ ROLLER BAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other