BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR - 7CM

    MDR report key: 2161361 · Received July 13, 2011

    Report

    Report Number
    3005075853-2011-02875
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 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). 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. THE INSTRUMENT WAS RETURNED FOR ANALYSIS INTACT WITH THE SPACER ON THE DEVICE. BASED UPON THE VISUAL AND FUNCTIONAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON TIP HAD BEEN PULLED OFF OF THE SHAFT. LIKELY CAUSE OF THIS IS PULLING DOWN ON THE DEVICE WHILE STILL INSERTED AND BALLOON STILL INFLATED IN PATIENT. LOT UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: DID THE ISSUE OCCUR PRE-OPERATIVE OR INTRA-OPERATIVE? WAS THIS THE INITIAL USE OF THE DEVICE? HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE? WHAT OTHER DEVICES WERE USED IN CONJUNCTION WITH THE DEVICE? WAS THE SALES REP PRESENT DURING THE EVENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE BALLOON COULD NOT BE EXPANDED WHEN THE AIR WAS INJECTED. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS FOUND THAT THE BALLOON HAD BURST. THEY STOPPED USING THE DEVICE ON THE PATIENT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1