BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE X-TRACT MOTOR DRIVE UNIT

    MDR report key: 3252784 · Received July 29, 2013

    Report

    Report Number
    2210968-2013-14934
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2013. IN THE MIDDLE OF THE PROCEDURE, THE DEVICE STARTED TO FLICKER AND THEN SHUT DOWN. THE PHYSICIAN TRIED TO USE THE DEVICE SEVERAL TIMES WITH THE SAME RESULTS. THE CASE WAS CONVERTED FROM A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY TO A HYBRID LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY/ VAGINAL SUPRACERVICAL HYSTERECTOMY. IN ORDER TO FINISH THE PROCEDURE, A COLPOTOMY WAS PERFORMED AND MORCELLATION WAS CONDUCTED MANUALLY THROUGH THE VAGINA. APPROXIMATELY 250 GRAMS OF THE UTERUS WAS REMOVED THROUGH THE COLPOTOMY WITH THE ASSISTANCE OF LAPAROSCOPIC VISUALIZATION THROUGH THE ABDOMEN. UPON COMPLETION OF MORCELLATION, THE COLPOTOMY WAS SUTURED AND THE PROCEDURE WAS FINISHED WITH CERVIX INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPERCERVICAL HYSTERECTOMY ON (B)(6) 2013. IN THE MIDDLE OF THE PROCEDURE, THE DEVICE STARTED TO FLICKER AND THEN SHUT DOWN. THE PHYSICIAN TRIED TO USE THE DEVICE SEVERAL TIMES WITH THE SAME RESULTS. THE CASE WAS CONVERTED FROM A LAPAROSCOPIC SUPERCERVICAL HYSTERECTOMY TO A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354079 GYNECARE X-TRACT MOTOR DRIVE UNIT LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON INC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention