BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 3021690 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02849
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PROCEDURE WAS A HYSTERECTOMY. DURING THE PROCEDURE, THE DEVICE WAS STALLING OUT AND STOPPED WORKING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO MORCELLATE A FIBROID AND THE HANDPIECE WOULD NOT MORCELLATE THE FIBROID. THE PHYSICIAN ADJUSTED THE SPEED SETTING ON THE DEVICE AND STILL COULDN'T MORCELLATE THE FIBROID. THE PHYSICIAN REPORTED THE PLAN WAS TO PLACE THE HANDPIECE IN COREGUARD MODE AND PERFORM A SHAVING METHOD AROUND THE FIBROID TO REMOVE THE FIBROID. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123362 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1