BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 2232275 · Received September 2, 2011

    Report

    Report Number
    3005075853-2011-03629
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 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 ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.ADDITIONAL INFORMATION:DID THE ISSUE OCCUR PRE-OPERATIVE OR INTRA-OPERATIVE? ---INTRA-OPERATIVE.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.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED UPON THE VISUAL AND FUNCTIONAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON ON THE RETURNED DEVICE HAS BEEN CUT, LIKELY BY A GRASPER. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY, THE BALLOON WAS BURST. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE MANIPULATOR - 7CM LKF ETHICON ENDO-SURGERY, LLC. NA H43X08

    Patients

    Seq Age Sex Outcome Treatment
    1