BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 2251813 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03835
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 29, 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). CUT. TWO INSTRUMENTS WERE RETURNED FOR DEVICE EVALUATION. BOTH INSTRUMENTS WERE RETURNED INTACT BUT WITHOUT THE SPACER ON THE DEVICE. BASED UPON THE VISUAL AND FUNCTIONAL EXAMINATION, IT WAS CONCLUDED THAT THE CUT IN THE BALLOON CAUSED BY A SHARP INSTRUMENT. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WAS THIS THE INITIAL USE OF THE DEVICE? ---YES. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE? ---NO INFORMATION. WHAT OTHER DEVICES WERE USED IN CONJUNCTION WITH THE DEVICE? ---NO INFORMATION. WAS THE SALES REP PRESENT DURING THE EVENT? ---NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE, THE BALLOON WAS BURST IN EACH DEVICE. THE INJECTED AMOUNT OF THE 1ST DEVICE WAS 7ML, AND 2ND DEVICE WAS 6ML. ANOTHER 3RD DEVICE WAS USED TO COMPLETE THE CASE IN INJECTING 4ML. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE MANIPULATOR - 7CM LKF ETHICON ENDO-SURGERY, LLC. NA H4423N

    Patients

    Seq Age Sex Outcome Treatment
    1