BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 2478405 · Received March 5, 2012

    Report

    Report Number
    3005075853-2012-00913
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 10, 2012
    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? PRE. 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 HAD A CUT IN IT, LIKELY CAUSED BY A SHARP INSTRUMENT. THE BALLOON CAN BE EASILY COMPROMISED IF IT COMES IN CONTACT WITH A SHARP OBJECT OR PACKAGING MATERIAL. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN OOPHORECTOMY, THE BALLOON HAD BEEN BURST. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. 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 H44YOD

    Patients

    Seq Age Sex Outcome Treatment
    1