BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGHOLDER, POWER-ASSTED ,MAQ (1005.86B0)

    MDR report key: 23234933 · Received October 7, 2025

    Report

    Report Number
    3010216206-2025-00025
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 5, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FWZ
    UDI-DI
    00615521017880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITHOTOMY POSITIONER STIRRUP IS USED IN PLACING THE PATIENT IN THE LITHOTOMY POSITION IN PREPARATION FOR A PROCEDURE. THE DEVICE'S VELCRO STRAP, WHICH SECURES THE PATIENT'S FOOT AND LEG, IS SECURED TO THE BOOT USING A STAPLE AND ADHESIVE. IFU STATES YOU SHOULD ALWAYS CONFIRM THE WORKING ORDER PRIOR TO USING IT CLINICALLY. IN THE EVENT A DEVICE FAILURE WAS TO OCCUR, OR THE DEVICE WAS THOUGHT TO BE UNRELIABLE, THE DEVICE WOULD NOT BE USED, AND A BACKUP DEVICE WOULD LIKELY BE AVAILABLE FOR IMMEDIATE USE. DISTRIBUTOR'S FIELD SERVICE TECHNICIAN DETERMINED THAT THE GAS CYLINDER, PIVOT MOUNT AND PADS NEEDED TO BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE DEVICE AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE REPAIR, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A LEG HOLDER COLLAPSING WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

    Additional Manufacturer Narrative · 0

    BAXTER IS IN THE PROCESS OF INSPECTING THE LEG HOLDER. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE LEG HOLDER AT THIS TIME. THE INVESTIGATION IS ONGOING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW UP REPORT AND THE EVENT WILL BE CATEGORIZED ACCORDINGLY.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT STATING THAT LEG HOLDER FELL COMPLETELY AND COLLAPSED WHILE A PATIENT WAS ON THE TABLE. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT STATING THAT LEG HOLDER FELL COMPLETELY AND COLLAPSED WHILE A PATIENT WAS ON THE TABLE. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869219 LEGHOLDER, POWER-ASSTED ,MAQ (1005.86B0) OPERATING ROOM ACCESSORIES TABLE TRAY FWZ BAXTER HEALTHCARE CORPORATION I-LHMAQ N/A 00615521017880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown