BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMEDICS FIBRIJET AEROSOL CONTROL UNIT

    MDR report key: 1658764 · Received April 9, 2010

    Report

    Report Number
    MW5015525
    Event Type
    Injury
    Date Received
    April 9, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 9, 2010
    Manufacturer
    MICROMEDICS
    Product Code
    KDP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NEW PRESSURIZED SYSTEM THAT WAS NITROGEN POWERED WAS USED FOR THIS CASE WHICH INVOLVED THE USE OF A FOOT PEDAL. THE SYSTEM WAS USED WITHOUT INCIDENT VAGINALLY. THE SYSTEM WAS AGAIN USED FOR A SECOND LOOK AFTER VAGINAL HYSTERECTOMY HAD BEEN COMPLETED TO PROMOTE HEMOSTASIS HOWEVER, DURING EXAMINATION, THE FOOTPEDAL MALFUNCTIONED -MAXIMUM PRESSURE WAS 20PSI- AND THE PRESSURE ON THE GAUGE CONTINUED TO INCREASE. THE REP FROM BIOMET BIOLOGICS STEPPED ON THE FOOT PEDAL BUT THE ABDOMINAL PRESSURE CONTINUED TO INCREASE. THE REP TRIED TO PULL THE KNOB OUT TO LOCK THE GAUGE BUT DID NOT WORK. THE REP HAD TO ULTIMATELY UNPLUG THE DEVICE FROM THE AIR GAUGE -(B) (4)-. IT WAS THEN NOTED THAT FOLEY BAG WAS FILLED WITH GAS/AIR. UROLOGY SURGEON WAS CALLED IN FOR CONSULT AND CYSTOSCOPY WAS DONE. PT WAS RESCOPED LAPAROSCOPICALLY. DATE OF USE: (B) (6) 2010. DIAGNOSIS: LAPAROSCOPY, TOTAL VAGINAL HYSTERECTOMY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMEDICS FIBRIJET AEROSOL CONTROL UNIT REGULATOR PRESSURE GAUGE KDP MICROMEDICS SA-6030 27711

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability