BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 2191456 · Received August 4, 2011

    Report

    Report Number
    3005075853-2011-03191
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LKF
    PMA / PMN Number
    K940681
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT WORK INSIDE THE UTERUS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AND CHECKED, IT WAS FOUND THAT THE BALLOON HAD BEEN BURST. NO PIECES WERE LEFT INSIDE THE PATIENT. THE INJECTED NORMAL SALINE WAS LESS THAN 10CC. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE MANIPULATOR - 7CM LKF ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1