BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2760524 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05593
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE, THE DEVICE WAS STALLING. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-05592, MEDWATCH 2210968-2012-05594, MEDWATCH 2210968-2012-05595 AND MEDWATCH 2210968-2012-05596. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE TRIGGER OF THE DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2012. DURING THE PROCEDURE, THE DEVICE WAS STALLING. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT216925

    Patients

    Seq Age Sex Outcome Treatment
    1