BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2535274 · Received April 13, 2012

    Report

    Report Number
    2210968-2012-01091
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF FACILITY REPORT # (B)(4). THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2012-01088, 2210968-2012-01089, AND 2210968-2012-01090. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE BLADE FAILED TO ROTATE DURING THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED LAPAROSCOPIC MYOMECTOMY WITH LYSIS OF ADHESIONS ON (B)(6) 2012. DURING THE PROCEDURE, THE DEVICE FUNCTIONED INTERMITTENTLY, THEN STOPPED CUTTING. THE DEVICE WAS TRIED IN FULL AND IN COREGUARD MODE WHEN TROUBLE SHOOTING, BUT IT STOPPED MORCELLATING. THE DEVICE BECAME INOPERABLE. THE PROCEDURE THAT WAS INTENDED WAS PERFORMED AND WAS COMPLETED BY CAUTERIZING AND CUTTING THE FIBROID AND PULLING IT OUT. THE LOWER LEFT QUADRANT INCISION WAS ENLARGED FROM APPROXIMATELY 7MM TO APPROXIMATELY 14MM. CURRENTLY, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT215917

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention