BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2900126 · Received January 7, 2013

    Report

    Report Number
    2210968-2013-00147
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00145 AND MEDWATCH 2210968-2013-00146. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00146 AND MEDWATCH 2210968-2013-00142. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANTLY, THE PATIENT UNDERWENT A LEFT SALPINGO OOPHORECTOMY AND EXCISION OF A LEFT PARATUBAL CYST. DURING THE PROCEDURE, THE MOTOR DRIVE WAS ACTIVATING INTERMITTENTLY AND THE DEVICE WAS STALLING. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2012. DURING THE PROCEDURE, THE MOTOR DRIVE WAS ACTIVATING INTERMITTENTLY AND THE DEVICE WAS STALLING. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8056 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT217058

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR