BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN STERILIZER COMPANY

    MDR report key: 283 · Received March 5, 1992

    Report

    Report Number
    283
    Event Type
    Injury
    Date Received
    March 5, 1992
    Date of Event
    February 19, 1992
    Report Date
    February 25, 1992
    Manufacturer
    AMSCO
    Product Code
    FWX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    WHILE POSITIONING TABLE IN REVERSE TRANDELENBERG CRANK WOULD NOT TURN AT SURGEONS INSISTENCE CRANK WAS FORCED CAUSING A NOISE AND THE TABLE TO JUMP. NURSE'S TOE WAS FRACTURED DURING THE INCIDENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-DEC-91. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN STERILIZER COMPANY N/A FWX AMSCO 1080M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention