BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 SPHERICAL PROBE

    MDR report key: 8190444 · Received December 21, 2018

    Report

    Report Number
    1216677-2018-00090
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 5, 2018
    Report Date
    December 29, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF (B)(4). *INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS NO SIMILAR ISSUES. A REVIEW OF THE DHR REVEALS NO ANOMALIES. SERVICE & REPAIR CONFIRMED THE COMPLAINT. MOISTURE WAS NOTED INSIDE THE UNIT. ANY MOISTURE THAT MAKES IT WAY INSIDE THE SPRING ASSEMBLY WILL INTERFERE WITH THE PROPER FUNCTION OF THE SPRING ASSEMBLY. THE SPRING ASSEMBLY IS MADE UP OF A SPRING WITH A BALL END. THE BALL END IS SET TO MOVE UNDER A RANGE OF PRESSURE SO THAT ITS SEATING PRESSURE IS A MAXIMUM. THE POSITION OF THE BALL AND THE FLOW OF GAS AROUND IT PRODUCES THE DESIRED DROP IN TEMPERATURE AT THE TIP OF THE PROBE. ALL THIS IS INTERNAL WITHIN THE PARTICULAR TIP. IN THIS CASE, P/N 139. THE PRESSURE NEEDED TO SEAT THE BALL WAS DETERMINED TO BE HIGHER THAN THE SPECIFICATION FOR THIS PROBE. THIS CONFIRMS MOISTURE IS PRESENT AS THE COLD WILL TURN IT TO ICE PARTICLES INTERFERING WITH THE PROPER MOVEMENT OF THE SPRING ASSEMBLY INSIDE. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO END USER ERROR. MOITURE ENTRY IS POSSIBLE THROUGH THE AUTOCLAVING PROCESS, STERILIZATION. IT CAN ENTER VIA THE EXHAUST PORT OR THE FILTER IF EITHER END OR BOTH ARE IN THE PAN PARTIALLY SUBMERGED IN THE WATER. THE IFU STATES 'DO NOT IMMERSE PROBE IN ANY SOLUTION.' *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS RE-WORKED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER AT A CHARGE. THIS COMPLAINT WILL BE ENTERED INTO THE COOPERSURGICAL CONTINUOUS IMPROVEMENT PLAN (CIP). NO APPLICABLE CORRECTION AVAILABLE TO TRAIN TO AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? YES *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    PER CUSTOMER'S STATEMENT ON REPAIR AUTHORIZATION FORM " FREEZES". REFERENCE REPAIR ORDER: 90526. REF (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PER CUSTOMER'S STATEMENT ON REPAIR AUTHORIZATION FORM " FREEZES". REFERENCE REPAIR ORDER:(B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031034 N20 SPHERICAL PROBE N20 SPHERICAL PROBE HQA COOPERSURGICAL, INC. 139 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other