BEUDAMED
    FDA Adverse Event Other Summary report: N

    COOK ASPIRATOR

    MDR report key: 536132 · Received June 25, 2004

    Report

    Report Number
    536132
    Event Type
    Other
    Date Received
    June 25, 2004
    Date of Event
    May 31, 2004
    Report Date
    June 22, 2004
    Manufacturer
    COOK OB/GYN
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INFERTILITY PT WAS UNDERGOING A TRANS-VAGINAL ULTRASOUND GUIDED FOLLICULAR ASPIRATION FOR EGG RETRIEVAL. AFTER SETTING UP THE STERILE FIELD, THE RN (REGISTERED NURSE) FLUSHED THE NEEDLE AND THEN SUCTIONED THE FLUID OUT OF THE TEST TUBE. THE RN HANDED THE SUCTION TO THE PHYSICIAN WHO USED THE FOOT PEDAL TO SUCTION. THE PHYSICIAN INSERTED THE NEEDLE INTO THE VAGINA AND INTO A FOLLICLE AND PRESSED ON THE FOOT PEDAL. THE BLUE LIGHT ON THE MACHINE CAME ON BUT NO SUCTION OCCURRED. THERE WAS NO BEEPING OR OTHER INDICATION OF MALFUNCTION. CHECKED THE TUBING, TEST TUBE AND NEEDLE WITHOUT FINDING ANY CONTRIBUTING FACTORS. EGGS WERE FINALLY REMOVED BY HAND SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK ASPIRATOR SUCTION MACHINE JCX COOK OB/GYN K-MAR-5100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR