BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 1904980 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06606
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LKF
    PMA / PMN Number
    K940681
    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. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT B WAS RETURNED INTACT FOR ANALYSIS WITH THE SPACER ON DEVICE. ANALYSIS FOUND THE DEVICE CANNOT FUNCTION WITH THE TIP OF THE SHAFT PUSHED THROUGH THE BALLOON. BASED UPON THE VISUAL AND FUNCTIONAL EXAMINATION, IT WAS CONCLUDED THAT THE TIP OF THE SHAFT WAS PUSHED THROUGH THE BALLOON. THIS IS USER ABUSE. LOT G4TN61. INSTRUMENT C WAS RETURNED FOR ANALYSIS INTACT BUT WITHOUT THE SPACER ON THE DEVICE. ANALYSIS OF THE DEVICE SHOWS IT CANNOT FUNCTION WITH A CUT IN IT. BASED UPON THE VISUAL AND FUNCTIONAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON HAD A CUT IN IT, LIKELY CAUSED WITH A LASER OR OTHER CUTTER. LOT G4TJ8Z. THE LOT RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC TUBOPLASTY PROCEDURE, THE BALLOON OF THE FIRST DEVICE WAS BURST WHEN IT WAS INFLATED BEFORE USE ON THE PATIENT. THE ACRAL PART OF THE SECOND DEVICE WAS BROKEN OFF. WATER LEAKED AND THE BALLOON WAS NOT EXPANDED WHEN WATER WAS INJECTED INTO THE THIRD DEVICE. 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 UTERINE MANIPULATOR LKF ETHICON ENDO-SURGERY, LLC. G4TN7G

    Patients

    Seq Age Sex Outcome Treatment
    1