BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N2O SPHERICAL PROBE

    MDR report key: 11964574 · Received June 9, 2021

    Report

    Report Number
    1216677-2021-00127
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    April 23, 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
    NJ, 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 3/23/1998 UNDER WO #1169 AND SHIPPED ON 3/25/1998. 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 HAS BEEN SERVICED IN 2017 FOR A TORN SILICONE LINE/TUBE, 2018 FOR TRAPPED MOISTURE STUCK INSIDE, AND IN JANUARY 2021 FOR POOR SEATING CAUSING LOW FLOW AND THE FILTER WAS REPLACED. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED 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 TO FUNCTION PROPERLY. ROOT CAUSE: THE PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTIVE ACTIONS: THE UNIT WAS EVALUATED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    CUSTOMER STATED: "FREEZES WHILE HOLDING PROBE". 1216677-2021-00127-1, 139 N20 SPHERICAL PROBE, E-COMPLAINT- (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    PER CUSTOMER: FREEZES WHILE HOLDING PROBE. REPAIR LOG: (B)(4). N20 SPHERICAL PROBE 139. E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868461 N2O SPHERICAL PROBE N2O SPHERICAL PROBE HQA COOPERSURGICAL, INC. 139 N/A 00888937004168

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other