BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2902101 · Received January 8, 2013

    Report

    Report Number
    2210968-2013-00168
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    Manufacturer
    THE MEDTECH GROUP 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

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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 BLADE STOPPED ROTATING AND THE DEVICE DID NOT WORK AFTER FIFTEEN MINUTES OF MORCELLATING. A NEW DEVICE PACKAGE WAS OPENED AND THE SURGEON JUST TOOK THE BLADE FROM THE NEW DEVICE AND REMOVED THE BLADE FROM THE OLD DEVICE THAT WAS USED AND REATTACHED THE NEW BLADE FROM THE NEW DEVICE TO THE FIRST DEVICE HOUSING UNIT AND THEY WERE ABLE TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8551 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET THE MEDTECH GROUP INC. NA MT216548

    Patients

    Seq Age Sex Outcome Treatment
    1