BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 3070382 · Received April 22, 2013

    Report

    Report Number
    2210968-2013-04208
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 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

    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): 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 THE DEVICE WAS NOT LINING UP WITH THE DISPOSABLE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172216 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1