BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTOR ULTRASONIC SURGICAL ASPIRATOR

    MDR report key: 36316 · Received August 26, 1996

    Report

    Report Number
    1037831-1996-00011
    Event Type
    Injury
    Date Received
    August 26, 1996
    Date of Event
    June 12, 1996
    Report Date
    August 26, 1996
    Manufacturer
    ELEKTA UK
    Product Code
    LBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT INJURY OCCURRED. AFTER REVIEW OF THE MDR, IT CAN BE DETERMINED THAT THE INJURY OCCURRED DURING, OR AFTER, RESECTION OF A HIGHLY CALCIFIED MENINGIOMA TUMOR, USING A COMBINED ASPIRATOR AND GRASPING FORCEPS TECHNIQUE. EXPERIENCE OR LITERATURE HAS REVEALED THAT ASPIRATION IS NOT AS EFFECTIVE FOR STRUCTURES WITHOUT HIGH WATER CONTENT. THE INFARCTION, OR SWELLING WERE NOTED. HOWEVER, IT WAS FELT NECESSARY BY THE PHYSICIANS TO INDUCE BARBITUATE COMA IN ORDER TO MINIMIZE ANY CHANCES OF BRAIN INJURY THAT MIGHT ARISE AS A RESULT OF THE OPERATION. THE PT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT STILL INTUBATED, AND IN A BARBITUATE COMA. IT IS THE CO'S UNDERSTANDING THAT THE PT REMAINS IN A COMA STATE, HOWEVER, THIS CAN NOT BE ASCERTAINED AS CO PERSONNEL HAVE BEEN UNSUCCESSFUL IN OBTAINING FURTHER DETAILS OF THE INCIDENT, BEYOND WHAT WAS SUBMITTED TO THE FDA THROUGH MDR. CO WILL CONTINUE ITS EFFORTS TO INVESTIGATE THE INCIDENT SO THAT SUFFICIENT ANALYSIS AND ASSESSMENTS CAN BE MADE BY THE DEVICE MFR, AT WHICH TIME THE FDA WILL BE APPRISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOR ULTRASONIC SURGICAL ASPIRATOR ULTRASONIC ASPIRATOR LBK ELEKTA UK SELECTOR PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability