BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2760443 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05588
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 3, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    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. 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 GYNECOLOGICAL PROCEDURE ON (B)(6) 2012. DURING THE PROCEDURE, THE TRIGGER OF THE DEVICE WAS PRESSED, BUT THE BLADE WOULD NOT ADVANCE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT216266

    Patients

    Seq Age Sex Outcome Treatment
    1