BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 CV RETINAL SUPER

    MDR report key: 10398637 · Received August 12, 2020

    Report

    Report Number
    1216677-2020-00172
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 13, 2020
    Report Date
    January 27, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    UDI-DI
    00888937004069
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INSPECT RETURNED SAMPLES: REVIEW DHR. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 8/25/2014 UNDER WO #: (B)(4) AND SHIPPED ON 8/12/2015. MANUFACTURING RECORD REVIEW: DHR (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS RETURNED ONCE IN 2015 (LOG 80853) WITH NO ISSUES CONFIRMED. IN JULY OF 2019 THE UNIT WAS RETURNED (LOG 92463) FOR A TEAR IN THE SILICONE TUBING. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO 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 THE BLUE THERMOCOUPLE WIRE WAS PINCHED. ROOT CAUSE: A PINCHED THERMOCOUPLE WIRE IS CONSISTENT WITH NO READINGS. THE ASSEMBLY REQUIRES THE WIRES RESIDE NEXT TO THE FEEDER TUBING ALL WITHIN THE BOILER. INITIAL TESTING FOR A READOUT IS EXECUTED ON EACH UNIT DURING PRODUCTION. A FAILURE OF THIS KIND INDICATES THE BOILER WAS INCORRECTLY MANIPULATED BY THE END USER CREATING THE LIKELIHOOD OF A PINCHED WIRE INSIDE. CORRECTIVE ACTIONS: THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS 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: "THE EQUIPMENT DID CONTINUE TO WORK IN ORDER TO COMPLETE THE PROCEDURE. THE TEMPERATURE JUST WOULD NOT CONTINUE READING FOR THE DOC TO SEE EXACTLY WHAT TEMP IT WAS AT". 161 N20 CV RETINAL SUPER (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION IS BEING INVESTIGATED BY COOPERSURGICAL, INC.

    Description of Event or Problem · 1

    NOT READING TEMP. ORDER: 94589. REF E-COMPLAINT-(B)(4). N20 CV RETINAL SUPER 161 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864113 N20 CV RETINAL SUPER N20 CV RETINAL SUPER HQA COOPERSURGICAL, INC. 161 N/A 00888937004069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other