BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 489508 · Received October 16, 2003

    Report

    Report Number
    2210968-2003-00407
    Event Type
    Injury
    Date Received
    October 16, 2003
    Date of Event
    September 9, 2003
    Report Date
    September 16, 2003
    Manufacturer
    MEDSOURCE TECHNOLOGIES
    Product Code
    HFG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A MYOMECTOMY PROCEDURE THE BLADE OF THE MORCELLATOR DID NOT RETRACT WHEN THE SURGEON PRESSED "OFF". THE SURGEON ADVANCED THE DEVICE AND NICKED THE BOWEL. SURGERY TIME WAS EXTENDED TWO HOURS IN ORDER TO REPAIR THE BOWEL. THE PT DID WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR MORCELLATOR HFG MEDSOURCE TECHNOLOGIES NA MS060302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention