BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS

    MDR report key: 11398740 · Received March 2, 2021

    Report

    Report Number
    11398740
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 22, 2021
    Report Date
    February 2, 2021
    Manufacturer
    STERIS CORPORATION
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROCEDURE UNDERWAY WITH PATIENT IN SUPINE POSITION SECURED TO OPERATING TABLE. SURGEON REQUESTED MOVING TABLE TO TRENDELENBURG POSITION. THIS WAS PERFORMED UTILIZING BED REMOTE. IMMEDIATELY AFTER REPOSITIONING, NOISE HEARD FROM BED AND HOB OBSERVED SEVERAL INCHES LOWER FROM LAST POSITION. FINAL POSITION OBSERVED LOWER AND MORE TOWARDS HOB THAN DESPITE NO USER ADJUSTMENT TO BED. PT. REMAINED SECURED TO BED. ALL EXTREMITIES CHECKED. ETT REMAINS IN PLACE. VSS. POSITIONED IN SUPINE POSITION AND SLID BED WITH REMOTE TOWARD LEGS. SURGEON DIAGNOSED IATROGENIC BOWEL INJURY REQUIRING CONVERSION TO OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295566 STERIS TABLE, OPERATING-ROOM, AC-POWERED FQO STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33945 DA