BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 3021713 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02845
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE MOTOR DRIVE UNIT END OF THE DRIVE CABLE WAS FOUND TO BE INTACT WITH NO DAMAGE.

    Additional Manufacturer Narrative · 1

    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 TRIGGER INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE MAIN HOUSING WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, THE TRIGGER OPERATED AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE METAL TIP AT THE END OF THE TUBING THAT CONNECTS INTO THE MOTOR DRIVE WAS BENT. THE DEVICE RAN, BUT IT WAS INTERMITTENT AND SLOW. THE DEVICE WAS INSERTED INTO THE PATIENT'S CAVITY SO THERE WAS PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, WHILE PLUGGING DEVICE IN, THERE WAS NO APPROPRIATE SOUND. WHEN THE DEVICE WAS REMOVED FROM THE MACHINE, IT WAS NOTED THAT THE TIP WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124269 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT217745

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR