BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOTOMY LEG HOLDER

    MDR report key: 11749907 · Received April 29, 2021

    Report

    Report Number
    1043572-2021-00030
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 29, 2021
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    BWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITHOTOMY LEG HOLDER WAS RETURNED AND EVALUATED BY STERIS, AND IT WAS DETERMINED THAT THE REPORTED EVENT IS ATTRIBUTED TO THE SUPPORT ASSEMBLY ROD NOT BEING FULLY SEATED. AS THE SUPPORT ASSEMBLY ROD WAS NOT FULLY SEATED, THIS ALLOWED FOR THE PIN WHICH LOCKS THE SUPPORT ASSEMBLY ROD IN PLACE TO MISS THE SUPPORT ASSEMBLY ROD AND SLIP OUT OF THE BOSS (CONNECTION POINT). THE TECHNICIAN REPLACED THE LEG HOLDER, TESTED THE UNIT, CONFIRMED IT WAS OPERATING ACCORDING TO SPECIFICATION AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS PROVIDED WITH A REPLACEMENT LITHOTOMY LEG HOLDER. THE LITHOTOMY LEG HOLDER IS BEING SENT BACK TO STERIS FOR FURTHER EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR LITHOTOMY LEG HOLDER MOVED DOWNWARD DURING A PATIENT PROCEDURE. THE LITHOTOMY LEG HOLDER WAS REPLACED BY OR STAFF RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647186 LITHOTOMY LEG HOLDER LEG HOLDER BWN STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1