BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 3010184 · Received March 19, 2013

    Report

    Report Number
    2210968-2013-02583
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    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 DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, DURING THE ANNUAL PM, IT WAS NOTED THAT THE DRIVE CONNECTOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113185 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1