BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMSCO QUANTUM 3080RC/RL SURGICAL TABLE

    MDR report key: 275567 · Received April 20, 2000

    Report

    Report Number
    1043572-2000-00001
    Event Type
    Other
    Date Received
    April 20, 2000
    Date of Event
    March 23, 2000
    Report Date
    March 23, 2000
    Manufacturer
    STERIS CORP.
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, WITH THE LEG SECTION IN THE FULL DOWN POSITION AND THE DR RESTING THE FOOT ON THE TABLE PEDESTAL BASE, SOMEONE LOWERED THE TABLE. THIS COMBINATION OF EVENTS CAUSED DR'S FOOT TO BE CAUGHT BY THE DOWNWARD MOTION, CAUSING THE INJURY. THE DR SUSTAINED AN INJURY TO FOOT THAT REQUIRED SUTURES. ON-SITE INVESTIGATION BY THE STERIS SVC TECH INDICATES THAT USER ERROR LED TO THE EVENT. INSPECTION AND EVALUATION OF THE TABLE BY THE TECH DID NOT INDICATE ANY MALFUNCTION OF THE TABLE AND IN FACT THE TABLE WAS IN USE AT THE FACILITY WHEN THE TECH ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO QUANTUM 3080RC/RL SURGICAL TABLE SURGICAL TABLE FQO STERIS CORP. 3080RC/RL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other