BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 3240932 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-13991
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4): 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 TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE BLADE STARTED TO ROTATE AND THEN WOULD NOT ROTATE. THE DEVICE WAS UNABLE TO MORCELLATE AT ALL. THE CASE WAS UNABLE TO BE COMPLETED LAPAROSCOPICALLY AND WAS CONVERTED TO AN OPEN HYSTERECTOMY. THE CURRENT CONDITION OF THE PATIENT IS NO COMPLICATIONS AND DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340627 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention