BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2902104 · Received January 8, 2013

    Report

    Report Number
    2210968-2013-00162
    Event Type
    Injury
    Date Received
    January 8, 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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE MAIN HOUSING WAS RETURNED IN DISASSEMBLED CONDITION. THE RELATIVE ROTATION BETWEEN INNER SHEATH AND DRIVE TUBE WAS FROZEN.

    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. 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 PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2012. DURING THE PROCEDURE, THE DEVICE WORKED PROPERLY AT FIRST. AFTER A QUARTER OR HALF OF THE MYOMA WAS CUT, THE BLADE WAS GETTING DULL RAPIDLY AND STOPPED ROTATING. THE SURGEON DECIDED TO EXTEND THE INCISION ABOUT ONE CM, AND CUT THE MYOMA WITH A SURGICAL KNIFE. THE PROCEDURE WAS COMPLETED. THERE ARE NO FUTURE PLANS FOR THE PATIENT. CURRENTLY, THE PATIENT IS GETTING WELL AND STILL HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8552 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT217153

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R