BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 CV RETINAL SUPER

    MDR report key: 8191023 · Received December 21, 2018

    Report

    Report Number
    1216677-2018-00091
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 7, 2018
    Report Date
    December 18, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS E-COMPLAINT (B)(4) WAS THE COMPLAINT CONFIRMED? YES. THE COMPLAINT UNIT, SERIAL (B)(6), WAS MANUFACTURED IN JANUARY AND SHIPPED IN JULY OF 2015. A REVIEW OF THE 2 YEAR COMPLAINT HISTORY FOR THE N20 CV RETINAL SUPER, ITEM #161, SHOWS SIMILAR REPORTED COMPLAINT CONDITIONS. DHR-161-177377 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. REPAIR ORDER (B)(4) NOTES: CUST STATES: LEAKS, ONLY GETS TO -40, TAKES LONG TIME TO DEFROST. FOUND: POOR SEATING. REWORKED SPRING HOUSING ASSY. TESTED TO SOP-MFG-51505 SPECS. THE COMPLAINT WAS CONFIRMED. POOR SEATING IS WHEN THE BALL SEATS SLOWLY AND INCOMPLETELY BECAUSE THE VALVE IS DIRTY. OVER TIME, DIRT AND DUST MAY ACCUMULATE IN THE SPRING HOUSING ASSEMBLY. WHEN THE ACCUMULATION REACHES A CERTAIN POINT, THE BALL DOES NOT SEAT PROPERLY WHICH ALLOWS N2O TO FLOW FREELY OUT THE TIP OF THE PROBE, GIVING THE APPEARANCE OF LEAKING. IT, ALSO, REDUCES FREEZING EFFICIENCY. THEREFORE, WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THIS ISSUE MAY BE ATTRIBUTED TO WEAR AND TEAR. THESE DEVICES ARE 100% INSPECTED PRIOR TO RELEASE. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. *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 CORRECTIVE ACTIONS NECESSARY, AT THIS TIME. THIS IS NOT AN ASSEMBLY ISSUE. NO FURTHER TRAINING IS REQUIRED AT THIS TIME. COMPLAINTS WILL CONTINUE TO BE MONITORED TO DETERMINE IF THERE IS ANY NEW TREND FOR THIS COMPLAINT CONDITION. PREVENTATIVE ACTION ACTIVITY THE COMPLAINT WAS REVIEWED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    PER CUSTOMER'S STATEMENT ON REPAIR AUTHORIZATION FORM " FREEZES". REFERENCE REPAIR ORDER: (B)(4). REF E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PER CUSTOMER'S STATEMENT ON REPAIR AUTHORIZATION FORM " FREEZES". REFERENCE REPAIR ORDER: (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031775 N20 CV RETINAL SUPER N20 CV RETINAL SUPER HQA COOPERSURGICAL, INC. 161 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other