BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 3030952 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03298
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: NARRATIVE - IT WAS NOTED THAT THE VAGINA WAS EXCEEDINGLY SMALL, VERY DIFFICULT TO EVEN PLACE A SMALL UTERINE MANIPULATOR. THE UTERINE MANIPULATOR IN THE VAGINA RESULTING IN NEED FOR MORCELLATING TO REMOVE THE UTERUS. THE UTERUS WAS 14CM. PROCEDURE PERFORMED ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY AND CYTOSCOPY.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.IN ADDITION, A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-03299, MEDWATCH 2210968-2013-03301, AND MEDWATCH 2210968-2013-03302. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE OPERATED AS INTENDED DURING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY THROUGH A 12 PORT ON (B)(6) 2013. DURING THE PROCEDURE, THE LIGHTS ON THE FRONT OF THE DEVICE WERE FLASHING WHEN THE HANDPIECE WAS ACTIVATED. THE PHYSICIAN TRIED USING A SHAVING TECHNIQUE BUT TO NO AVAIL. THE PHYSICIAN USED LAPAROSCOPIC SCISSORS TO EASILY CUT AROUND THE FIBROIDS IN THE UTERUS AND CONTINUED PERFORMING THE TECHNIQUE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134613 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR