BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 21766836 · Received April 3, 2025

    Report

    Report Number
    1043572-2025-00033
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    February 24, 2025
    Report Date
    April 3, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    MDM
    UDI-DI
    50724995156386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES IS THE DISTRIBUTOR OF THE LB51 LIGHTHANDLE COVERS SUBJECT OF THE REPORTED EVENT. BASED ON THE DESCRIPTION OF THE REPORTED EVENT, THE LIKELY CAUSE OF THE REPORTED DETACHMENT WOULD BE ATTRIBUTED TO INCORRECT OR INCOMPLETE INSTALLATION OF THE COVER BY USER FACILITY PERSONNEL. STERIS ADVISED CARDINAL HEALTH TO COUNSEL USER FACILITY PERSONNEL ON THE PROPER INSTALLATION INSTRUCTIONS FOR THE LIGHTHANDLE COVERS. A 3-YEAR COMPLAINT REVIEW WAS PERFORMED FOR THE DEVICE AND CONFIRMED THIS TO BE AN ISOLATED EVENT FOR THE SUBJECT LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED THAT TWO OF THE LB51 LIGHTHANDLE COVERS DETACHED AND FELL INTO THE STERILE FIELD DURING A PATIENT PROCEDURE. USER FACILITY PERSONNEL RE-ESTABLISHED THE STERILE FIELD RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731513 NA LIGHTHANDLE COVER MDM STERIS CORPORATION 10990858 50724995156386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown