BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 SPHERICAL PROBE

    MDR report key: 11797485 · Received May 10, 2021

    Report

    Report Number
    1216677-2021-00092
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    February 26, 2021
    Report Date
    January 26, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    UDI-DI
    00888937004168
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 02/22/2002 UNDER WO (B)(4). AND SHIPPED ON 03/20/2002. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS RETURNED ONCE IN 2004 AND ONCE IN 2007 FOR CHECKS. UNIT WAS RETURNED IN 2017 FOR MILD CORROSION ON THE LATCH SPRING AND REPAIRED. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT HAD A CLOGGED UP FILTER. ROOT CAUSE: THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO WEAR AND TEAR. A CLOGGED FILTER ON A 19 YEAR OLD UNIT IS CONSIDERED NORMAL AND THE REASON A FILTER IS NEEDED. CORRECTIVE ACTIONS. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED "EVAL". THE REPAIR TECHNICIAN REPORTED: "FOUND - LOW DEFROST FLOW". 1216677-2021-00092-1 139 N20 SPHERICAL PROBE (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "EVAL". REPAIR TECH STATED "FOUND - LOW DEFROST FLOW - REPLACED FILTER". (B)(4). N20 SPHERICAL PROBE 139 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699951 N20 SPHERICAL PROBE N20 SPHERICAL PROBE HQA COOPERSURGICAL, INC. 139 N/A 00888937004168

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other