BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 2251859 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03837
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 22, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE BALLOON BURST WHILE FILLING AND ONLY 9CC OF FLUID WERE IN THE DEVICE. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE MANIPULATOR - 7CM LKF ETHICON ENDO-SURGERY, LLC. NA H4423C

    Patients

    Seq Age Sex Outcome Treatment
    1