BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5095 SURGICAL TABLE

    MDR report key: 18768382 · Received February 23, 2024

    Report

    Report Number
    1043572-2024-00014
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 23, 2024
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    UDI-DI
    00724995195649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE THREE SURGICAL TABLES (SERIAL NUMBERS: (B)(6)) SUBJECT OF THE REPORTED EVENT. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE TABLES AND FOUND ALL (B)(4) SURGICAL TABLES TO BE OPERATING ACCORDING TO SPECIFICATIONS. FOR THE TABLE THAT WAS LEAKING, THE TECHNICIAN FOUND THE FLOOR LOCK WAS REMOVED AND THAT THE CUSTOMER HAD ALREADY REATTACHED THE HYDRAULIC LINE. NO LEAK WAS FOUND AND THE FLOOR LOCK WAS REPLACED WITH A NEW ONE. OUT OF AN ABUNDANCE OF CAUTION, THE TECHNICIAN DID REPLACE THE FLOOR LOCKS FOR THE OTHER TWO SURGICAL TABLES. THE THREE SURGICAL TABLES WERE TESTED, CONFIRMED TO BE OPERATIONAL, AND RETURNED TO SERVICE. BASED ON THE DESCRIPTION OF THE EVENT AND THE TECHNICIAN'S INSPECTION, THE REPORT IS LIKELY ATTRIBUTED TO IMPROPER CLEANING PRACTICES AS LOCKING THE SURGICAL TABLE DOWN ON WET FLOORING COULD CREATE A VACUUM SEAL BETWEEN THE FLOOR LOCK FEET AND THE FLOORING. THE STERIS (B)(4) SURGICAL TABLE OPERATOR MANUAL STATES (SECTION 7.2), "AFTER EACH WEEKLY USE OF THIS SURGICAL TABLE, CLEAN/ DISINFECT TABLE AS FOLLOWS: 1. PERFORM STEPS 1 THROUGH 4 OF AFTER EACH USAGE. 2. CHECK TABLE CASTERS AND FLOOR LOCKS FOR ANY ACCUMULATED DEBRIS AND CLEAN AS FOLLOWS: A. ENSURE FLOOR LOCKS ARE PROPERLY ENGAGED (RAISING CASTERS OFF FLOOR). B. HOLD CLEANER SPRAY CAN 6-8" (152-203 MM) FROM CASTER AND SPRAY CLEANING FLUID LIBERALLY ON THE CASTER. C. WIPE CASTER WITH A CLOTH, DAMPENED WITH WATER, TO REMOVE CLEANING FLUID AND DEBRIS. D. PERFORM STEP B AND STEP C FOR REMAINING THREE CASTERS." A STERIS ACCOUNT MANAGER COUNSELED THE USER FACILITY PERSONNEL ON PROPER CLEANING PRACTICES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PRIOR TO THE START OF A PATIENT PROCEDURE THE FLOOR LOCKS ON (B)(4) OF THEIR (B)(4) SURGICAL TABLES WOULD NOT DISENGAGE FROM THE FLOOR AND IN ADDITION (B)(4) OF THE TABLES WAS LEAKING OIL NEAR THE LEG OF THE TABLE. A 15-MINUTE DELAY OCCURRED AS A RESULT OF THE EVENT. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128937 5095 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY 00724995195649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown