BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2943824 · Received February 5, 2013

    Report

    Report Number
    2210968-2013-00777
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE MAIN HOUSING WAS NOT RECEIVED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, IN THE ABSENCE OF ALL COMPONENTS BEING RETURNED, IT WAS UNABLE TO BE DETERMINED THAT THE DEVICE WAS NOT WORKING PRIOR TO SHIPPING. THE END OF THE DRIVE CABLE WAS FOUND TO BE BENT IN AS THE RECEIVED CONDITION. DUE TO THIS CONDITION, THE TRIGGER COULD NOT BE CONNECTED TO MOTOR DRIVE AND NO FURTHER TESTS INVOLVING TRIGGER HOUSING COULD BE PERFORMED. IF THE DRIVE CABLE WAS FORCED TO BE CONNECTED TO THE MOTOR DRIVE; THE DRIVE CABLE COULD HAVE BEEN BENT DUE TO EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE BLADE WOULD NOT ROTATE PRIOR TO FIRST USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORTER WAS UNCERTAIN IF DEVICE ALREADY HAD BEEN INSERTED INTO PATIENT AND USE ATTEMPTED PRIOR TO SWITCHING OUT DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47670 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT217345

    Patients

    Seq Age Sex Outcome Treatment
    1