BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V. MUELLER

    MDR report key: 19381354 · Received May 23, 2024

    Report

    Report Number
    1423507-2024-01017
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    February 20, 2024
    Report Date
    May 23, 2024
    Manufacturer
    STERIS CORPORATION
    Product Code
    JYG
    UDI-DI
    10885403008412
    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

    THE COMPLAINT INFORMATION WAS SENT TO THE SUPPLIER FOR EVALUATION. AN INVESTIGATION IS CURRENTLY IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE DEVICE SUBJECT OF THE REPORTED EVENT WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE, A ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE OPERATOR MANUAL FOR THE CURETTE STATES, "PRIOR TO USE, INSPECT DEVICES TO ENSURE PROPER FUNCTION AND CONDITION. DO NOT USE DEVICES IF THEY DO NOT SATISFACTORILY PERFORM THEIR INTENDED FUNCTION OR IF THEY HAVE PHYSICAL DAMAGE. AVOID MECHANICAL SHOCK OR OVERSTRESSING THE DEVICES. CLOSE DISTAL ENDS PRIOR TO INSERTION OR REMOVAL THROUGH CANNULAS. ALWAYS USE CAUTION WHEN INSERTING OR REMOVING DEVICES THROUGH THE CANNULA. LATERAL PRESSURE ON THE DEVICE DURING REMOVAL CAN DAMAGE THE WORKING TIP, AND/OR SHAFT OF THE DEVICE. BE SURE THE TIPS ARE CLOSED AND THE DEVICE IS PULLED STRAIGHT OUT UNTIL COMPLETELY CLEAR OF THE CANNULA TO AVOID CATCHING THE VALVE ASSEMBLIES IN CANNULAS OR DISLODGING THE CANNULA." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT NUMBER (B)(4) THAT DURING AN OPERATIVE PROCEDURE, THE CURETTE BROKE DURING USE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253664 V. MUELLER CURETTE JYG STERIS CORPORATION AU5600 (10)C21XSF 10885403008412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown