BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 RETINAL PRB CURVED

    MDR report key: 10310079 · Received July 22, 2020

    Report

    Report Number
    1216677-2020-00160
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 13, 2020
    Report Date
    September 24, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION : X-REVIEW DHR , X-INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS : COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10/29/2018 UNDER WO #(B)(4) AND SHIPPED ON 6/9/2020. MANUFACTURING RECORD REVIEW: DHR 252192 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 NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED . VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: THE PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. THE PROBLEM DESCRIPTION IS CONSISTENT WITH INCORRECTLY OPERATING THE CONSOLE (CE-20000) AT 400 PSI, THEREFORE THIS IS ATTRIBUTABLE TO END USER ERROR. AS THE COMPLAINT CONFIRMED? NO . CORRECTION AND/OR CORRECTIVE ACTION THE CUSTOMER WAS PROVIDED WITH A NEW UNIT. THE COMPLAINT UNIT WAS CONVERTED TO A DEMO UNDER WO #(B)(4). NO FURTHER CORRECTIVE ACTION IS NECESSARY. PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    REPORT SUBMITTED BY CSI SERVICE & REPAIRS -OUT-OF BOX FAILURE- CRYO NOT MAKING PROPER TEMPERATURE. DETAILS OF INCIDENT: THIS NEW PROBE IS NOT WORKING PROPERLY. DR. VENTURI USED IT IN SURGERY FOR THE FIRST TIME TODAY. AND IT IS NOT FREEZING TO OPTIMAL TEMPERATURE AND WHEN IT FINALLY DOES REACH TEMPERATURE (-80) IT TAKE LIKE AT LEAST 50 SECONDS WHICH IS TOO LONG. FOLLOW-UP INITIATED FOR ADDITIONAL INFO ON IMPACT TO PATIENT. FOLLOW-UP RESPONSE STATED " PATIENT IS DOING WELL. NO ADVERSE EVEN RELATED, ADDITIONAL MEDICAL ATTENTION MAY LIKELY NEED TO REFREEZE DISTICHIA. PATIENT WAS UNDER GENERAL ANESTHESIA LONGER THAN USUAL DUE TO TROUBLE SHOOTING CRYO MACHINE AND PROBE. MAY NEED TO REPEAT PROCEDURE. (B)(4). 1216677-2020-00160 N20 RETINAL PRB CURVED 125 (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION IS BEING INVESTIGATED BY COOPERSURGICAL, INC. A FOLLOW UP REPORT WITH INVESTIGATION FINDINGS WILL BE FILED ONCE AVAILABLE. REF E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    REPORT SUBMITTED BY CSI SERVICE & REPAIRS -OUT-OF BOX FAILURE- CRYO NOT MAKING PROPER TEMPERATURE. DETAILS OF INCIDENT: THIS NEW PROBE IS NOT WORKING PROPERLY. DR. (B)(6) USED IT IN SURGERY FOR THE FIRST TIME TODAY. AND IT IS NOT FREEZING TO OPTIMAL TEMPERATURE AND WHEN IT FINALLY DOES REACH TEMPERATURE (-80) IT TAKE LIKE AT LEAST 50 SECONDS WHICH IS TOO LONG. FOLLOW-UP INITIATED FOR ADDITIONAL INFO ON IMPACT TO PATIENT. FOLLOW-UP RESPONSE STATED " PATIENT IS DOING WELL. NO ADVERSE EVEN RELATED, ADDITIONAL MEDICAL ATTENTION MAY LIKELY NEED TO REFREEZE DISTICHIA. PATIENT WAS UNDER GENERAL ANESTHESIA LONGER THAN USUAL DUE TO TROUBLE SHOOTING CRYO MACHINE AND PROBE. MAY NEED TO REPEAT PROCEDURE. REF E-COMPLAINT-(B)(4). N20 RETINAL PRB CURVED 125 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775935 N20 RETINAL PRB CURVED N20 RETINAL PRB CURVED HQA COOPERSURGICAL, INC. 125 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other