BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LB53 LIGHT HANDLE COVER

    MDR report key: 16330553 · Received February 8, 2023

    Report

    Report Number
    1043572-2023-00015
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 8, 2023
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTA
    UDI-DI
    00724995150136
    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

    STERIS HAS CONFIRMED THE REPORTED ISSUE. THE POLYBLEND PLASTIC MATERIAL THAT IS USED TO FORM THE LIGHT HANDLE COVER WAS SOURCED FROM A SECONDARY SUPPLIER BEGINNING IN OCTOBER 2022 AND MAY NOT MEET PERFORMANCE SPECIFICATIONS. STERIS INITIATED A RECALL (REMOVAL) OF THE AFFECTED PRODUCT ON MARCH 3, 2023.

    Additional Manufacturer Narrative · 0

    STERIS FILED MEDICAL DEVICE REPORT (MDR) 1043572-2023-00015 ON 2/8/2023 REGARDING THE REPORTED EVENT. MEDWATCH REPORT 0504240000-2023-8008 WAS RECEIVED (2/21/2023) FOLLOWING THE SUBMISSION OF MDR 1043572-2023-00015. A FOLLOW-UP MDR 1043572-2023-00015-01 WAS FILED ON 3/14/2023 WITH THE COMPLETED INVESTIGATION INFORMATION. THIS MDR IS BEING FILED TO ADDRESS THE RECEIPT OF MEDWATCH REPORT 0504240000-2023-8008.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. 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 LIGHT HANDLE COVER DETACHED AND FELL INTO THE STERILE FIELD. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606540 LB53 LIGHT HANDLE COVER LIGHT HANDLE COVER FTA STERIS CORPORATION - MONTGOMERY STERILE LIGHTHANDLE COVER 9799083 00724995150136

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown