BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE-2000 OPTHALMIC CRYO SYSTEM DIG

    MDR report key: 10923407 · Received November 30, 2020

    Report

    Report Number
    1216677-2020-00281
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 30, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGTION X-REVIEW DHR X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 7/20/2018 UNDER WO #(B)(4) AND SHIPPED ON 8/15/2018. MANUFACTURING RECORD REVIEW: DHR (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, 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 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 95224, THIS UNIT WAS AT CSI ON 11/6/2020. 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 HIGH PRESSURE REGULATOR HAD A SWOLLEN PIN CUSHION. ROOT CAUSE: A SWOLLEN PIN CUSHION INDICATES THE USER WAS NOT PROPERLY VENTING THE SYSTEM AFTER USE. PURGING THE SYSTEM OF RESIDUAL NITROUS OXIDE IS REQUIRED PER THE IFU AND INSTRUCTIONS ON THE TOP OF THE CONSOLE (P/N 34032). RESIDUAL GAS WILL SWELL THE PIN CUP WHICH WILL IMPACT ITS FUNCTION WITHIN THE REGULATOR. ROOT CAUSE IS BEING ATTRIBUTED TO END USER ERROR. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS REPAIRED, TESTED 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. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    E-COMPLAINT-(B)(4). NOT COOLING PROPERLY. UNIT NOT FREEZING QUICK ENOUGH. ORDER: (B)(4). FOUND;PIN CUP SWOLLEN,CUST NOT FOLLOWING PROPER SHUT DOWN. 1216677-2020-00281 OPTHALMIC CRYO SYSTEM DIG CE-2000 E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    E-COMPLAINT-(B)(4). NOT COOLING PROPERLY. UNIT NOT FREEZING QUICK ENOUGH. ORDER: (B)(4) FOUND;PIN CUP SWOLLEN,CUST NOT FOLLOWING PROPER SHUT DOWN. 1216677-2020-00281 OPTHALMIC CRYO SYSTEM DIG CE-2000 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384576 CE-2000 OPTHALMIC CRYO SYSTEM DIG CE-2000 OPTHALMIC CRYO SYSTEM DIG HQA COOPERSURGICAL, INC. 2000 -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other