BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 3211388 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12439
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE DID NOT CUT THE TISSUE EFFECTIVELY. ANOTHER LIKE DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310220 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. NA MT217375

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR