BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 1883911 · Received October 22, 2010

    Report

    Report Number
    2210968-2010-01358
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BLADE WILL NOT ROTATE: PRIOR TO FIRST USE. CONCLUSION: 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 BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2010. PRIOR TO FIRST USE, THE HAND PIECE WOULD NOT ACTIVATE. A SECOND HAND PIECE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT214338

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK