BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3080 SP SURGICAL TABLE

    MDR report key: 16078525 · Received December 30, 2022

    Report

    Report Number
    1043572-2022-00095
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 2, 2022
    Report Date
    December 30, 2022
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE SURGICAL TABLE AND FOUND THAT ONE OF THE TWO BOLTS THAT SECURES THE TILT CYLINDER TO THE TABLE'S COLUMN WAS DAMAGED RESULTING IN THE REPORTED TABLETOP MOVEMENT. THE TECHNICIAN REPLACED BOTH TILT CYLINDER BOLTS, TEST THE SURGICAL TABLE, FOUND IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED THE TABLE TO SERVICE. THE TABLE WAS INSTALLED IN 1996 MAKING IT APPROXIMATELY 26 YEARS OLD AND IS NOT UNDER STERIS SERVICE AGREEMENT. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. A 2-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AT THE START OF A PATIENT PROCEDURE THE TABLETOP TO THEIR 3080 SP SURGICAL TABLE WAS UNSTABLE. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238719 3080 SP SURGICAL TABLE SURGICAL TABLE FWW STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown