BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE-2000 OPTHALMIC CRYO SYSTEM DIG

    MDR report key: 9134246 · Received September 30, 2019

    Report

    Report Number
    1216677-2019-00268
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    August 26, 2019
    Report Date
    December 23, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF: E-COMPLAINT-(B)(4). INVESTIGATION: X-REVIEW DHR AND X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 7/20/18 UNDER WO #(B)(4) AND SHIPPED ON 10/4/18. MANUFACTURING RECORD REVIEW: DHR (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE ATTACHED 2-YEAR COMPLAINT HISTORY SHOWS SIMILAR REPORTED COMPLAINT CONDITIONS. VARIOUS OTHER REASONS CAN PRODUCE THE SAME PROBLEM DESCRIPTION USED FOR THIS COMPLAINT. NO RELATION TO THIS COMPLAINT IS EVIDENT. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 92739, THIS UNIT WAS AT CSI ON 9/03/19. 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'S LOW PRESSURE REGULATOR AND THE SHUTTER VALVE WERE NOT FUNCTIONING AS INTENDED. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. THE FAILURE OF A LOW PRESSURE REGULATOR (P/N 20346-1) IS RARE AND CONSIDERED AN ISOLATED INCIDENT. THE SHUTTLE VALVE WORKS WITH THE LOW PRESSURE REGULATOR AND WAS REPLACED AS A PRECAUTIONARY MEASURE AND A PRACTICAL STEP SINCE THE UNIT WAS ALREADY OPEN. THE LP REGULATOR WAS NOT CONTROLLING THE PRESSURE AND PUTTING OUT FULL PRESSURE OUT TO 3-WAY VALVE WHICH LETS THE FULL PRESSURE REACH THE REGULATOR AND TO THE PROBE. IT ALSO PUT HIGH PRESSURE, OR PRESSURE MUCH HIGHER THAN 90 PSI, TO THE SHUTTLE VALVE WHERE IT USUALLY DOESN'T GET EXPOSED TO THAT KIND OF PRESSURE FROM THAT SIDE. CORRECTION AND/OR CORRECTIVE ACTION: THE UNIT WAS FITTED WITH A NEW LOW PRESSURE REGULATOR AND SHUTTLE VALVE, TESTED TO SPECIFICATIONS, AND RETURNED TO THE CUSTOMER UNDER A WARRANTY REPAIR. 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. PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "UNIT DOES NOT STOP FREEZING" REFERENCE REPAIR ORDER #(B)(4). REFERENCE: E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL IS CURRENTLY EVALUATING THE DEVICE AND INVESTIGATING THE REPORTED CONDITION . A SUPPLEMENTAL REPORT WILL BE FILED ONCE THE EVALUATION AND INVESTIGATION ARE COMPLETED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED "UNIT DOES NOT STOP FREEZING". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931687 CE-2000 OPTHALMIC CRYO SYSTEM DIG CE-2000 OPTHALMIC CRYO SYSTEM DIG HQA COOPERSURGICAL, INC. CE-2000 2018070006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other