BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 1964769 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01718
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNK DATE. DURING THE PROCEDURE, WHEN THE SURGEON WENT TO CUT WITH THE BLADE, THE BLADE WOULD NOT ADVANCE. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPIC, GYNECOLOGIC FTL ETHICON, INC. NA MT214315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK