BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA

    MDR report key: 18507214 · Received January 12, 2024

    Report

    Report Number
    2028492-2024-00130
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 20, 2023
    Report Date
    February 5, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC.
    Product Code
    KPA
    UDI-DI
    04015630981052
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON THE COVER REPORTEDLY FELL IS BEING INVESTIGATED.

    Additional Manufacturer Narrative · 0

    THE LID COUNTERBALANCE AND IMAGES OF IT WERE REQUESTED FOR INVESTIGATION, BUT THESE COULD NOT BE PROVIDED. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH OVEREXTENSION OF THE HINGE DURING THE USE OF THE INSTRUMENT. MECHANICAL STOPS ON THE HINGE OF THE LID CONTROL HOW FAR THE HINGE WILL OPEN (85 DEGREES PLUS OR MINUS 5 DEGREES). OPENING OR FORCING THE LID PAST THE TYPICAL 85 DEGREES INCREASES THE CHANCES OF THE PIN AND CONNECTOR BUSHING DETACHING, ALLOWING THE COMPRESSION SPRING ASSEMBLY TO FALL OUT OF THE HINGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE WITH THE COVER OF THE BENCHMARK ULTRA STAINER MODULE. THE OPERATOR WAS LOADING REAGENTS AND THE COVER REPORTEDLY FELL ONTO THE OPERATOR'S WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817495 BENCHMARK ULTRA SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC. 04015630981052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown