BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 CATARACT PRB CURVED

    MDR report key: 12924954 · Received December 3, 2021

    Report

    Report Number
    1216677-2021-00271
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 3, 2021
    Report Date
    April 8, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION. X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS. DISTRIBUTION HISTORY. THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 12-28-11 UNDER WORK ORDER 116556 AND SOLD ON 3-8-12. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE 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 COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: THIS PRODUCT WAS PREVIOUSLY RETURNED ON 7-22-2020 FOR SERVICE LOG 94603 (REPLACED FILTER DUE TO LOW FLOW). HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. THERE WERE ADDITIONAL UNITS THAT REQUIRED REWORK OF THE SPRING HOUSING AND ONE ADDITIONAL UNIT RETURNED WITH NO THERMOCOUPLE. PRODUCT RECEIPT: THE COMPLAINT PRODUCT (P/N 127 S/N (B)(6)) WAS RETURNED ON 11-12-21. THE SERIAL NUMBER OF THE RETURNED PRODUCT MATCHED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE THERMOCOUPLE WAS NO LONGER PRESENT. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. NO LEAK WAS FOUND, HOWEVER THE SPRING HOUSING NEEDED ADJUSTING TO SPECIFICATION AND THE BOILER REQUIRED A NEW THERMOCOUPLE, SO THE ALTHOUGH THE COMPLAINT CONDITION WAS NOT CONFIRMED, THE UNIT WAS STILL FOUND NOT TO FUNCTION PROPERLY. *WAS THE COMPLAINT CONFIRMED? NO. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE WEAR AND TEAR DUE TO THE AGE OF THE RETURNED UNIT. FAILURE TO PURGE MOISTURE FROM THE PROBE CAN CAUSE CONDENSATION LEADING TO THE CORROSION OF THE THERMOCOUPLE OVER TIME. *CORRECTION AND/OR CORRECTIVE ACTION: THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER TRAINING REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PROBE LEAKS FOUND NO THERMO COUPLE REPAIR ORDER #: (B)(4) CATARACT PRB CURVED 127 E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    PROBE LEAKS. FOUND NO THERMO COUPLE. REPAIR ORDER #: (B)(4). 1216677-2021-00271 N20 CATARACT PRB CURVED 127 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819786 N20 CATARACT PRB CURVED N20 CATARACT PRB CURVED HQA COOPERSURGICAL, INC. 124 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other