BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 21472531 · Received February 26, 2025

    Report

    Report Number
    1043572-2025-00022
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 22, 2025
    Report Date
    February 26, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    EYD
    UDI-DI
    00724995217198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE POWERLIFT STIRRUPS SUBJECT OF THE REPORTED EVENT WERE RETURNED TO THE SUPPLIER FOR EVALUATION. THE SUPPLIER'S EVALUATION FOUND NO ISSUE WITH THE FUNCTION OR OPERATION OF THE STIRRUPS; THE REPORTED EVENT COULD NOT BE DUPLICATED. THE POWERLIFT STIRRUPS INSTRUCTIONS FOR USE STATES, "THE BOOT HAS A SELF-ADJUSTING DESIGN TO PROTECT THE CALF DURING RAISING OR LOWERING OF THE LEGS. IT IS FREE FLOATING AND MOVES WITH THE PATIENT'S LEG AS NEEDED." A STERIS ACCOUNT MANAGER PERFORMED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE STIRRUPS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IN PROGRESS. THE DEVICES SUBJECT OF THE REPORTED EVENT ARE BEING RETURNED FOR EVALUATION (SERIAL NUMBERS (B)(6)). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR POWERLIFT PLUS STIRRUPS WOULD NOT REMAIN IN THE LOCK POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT REPORT OF DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617457 NA STIRRUPS EYD STERIS CORPORATION POWERLIFT PLUS 00724995217198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown