BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 3211460 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12355
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 17, 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 Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - CONTINUOUS SPINNING OF BLADE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE WOULD NOT STOP ROTATING AT THE END. THE DEVICE WAS UNPLUGGED TO GET IT TO STOP ROTATING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309320 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1