BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2833045 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07291
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ETHICON, INC
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(4). BLADE SEIZED/STOPPED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE RELATIVE ROTATION BETWEEN THE DRIVE TUBE AND INNER/OUTER SHEATH WAS NOT FROZEN. HOWEVER, EVALUATOR NOTICE A CUT ALONG THE PERIPHERY OF AIR TUBE. DUE TO THIS CONDITION, THE DEVICE MIGHT HAVE STOPPED ROTATING DURING THE PROCEDURE. THE EXACT ROOT CAUSE OF THIS CONDITION COULD NOT BE DETERMINED FROM THE RESULTS OF EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2012. DURING THE PROCEDURE, THE DEVICE SEIZED UP AND STOPPED WORKING. 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
    1 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC NA MT217153

    Patients

    Seq Age Sex Outcome Treatment
    1