BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 SPHERIC RET SUPER

    MDR report key: 10337456 · Received July 29, 2020

    Report

    Report Number
    1216677-2020-00134
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    April 30, 2020
    Report Date
    March 3, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 7/13/2012 UNDER WO (B)(4) AND SHIPPED ON 7/19/2012. 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: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS AT CSI UNDER LOG (B)(4) ON 6/11/2013 FOR NOT SEATING. IT WAS BACK AT CSI UNDER LOG 84290 ON 12/2/2016 FOR A NON CONFIRMED ISSUE. 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 94252, THIS UNIT WAS AT CSI ON 5/7/2020. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. HOWEVER, THE UNIT WAS HEAVILY SOILED WITH RESIDUE ON THE TIP. THIS MATERIAL IS EXTERNAL TO THE DEVICE AND CONFIRMS THE TIP WAS NOT WIPED DOWN. POSSIBLY BETWEEN USES. THIS MATERIAL IS CONSIDERED AS THE 'FLAKING OFF' DEBRIS NOTED ON THE COMPLAINT. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT HAD NO (FUNCTIONING) THERMOCOUPLE, A HIGH FREEZE FLOW AND A LEAK IN THE DELIVERY LINE ASSEMBLY. ROOT CAUSE: THE UNIT WAS STILL IN USE BY THE END USER AND NOT RETURNED FOR THE FINDINGS NOTED ON THIS COMPLAINT, BUT FOR A SELF INDUCED ERROR ON THE END USER'S PART DUE TO POOR HANDLING BETWEEN USES. ROOT CAUSE IS BEING ATTRIBUTED TO END USER ERROR. CORRECTIVE ACTION: UNIT WAS REPAIRED, TESTED, AND RETURNED TO THE CUSTOMER AT A CHARGE. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. CLARIFICATION TO H.6. HEALTH EFFECT - CLINICAL CODE: FLAKING OFF INTO EYE.

    Description of Event or Problem · 0

    REPORTER STATED "THE END PART IS FLAKING OFF AND GOING INTO EYE DURING PROCEDURE." REF E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION IS BEING INVESTIGATED BY COOPERSURGICAL, INC.

    Description of Event or Problem · 1

    MAINTENANCE "THE END PART IS FLAKING OFF AND GOING INTO EYE DURING PROCEDURE." ORDER: (B)(4). REF (B)(4). 1216677-2020-00134 N20 SPHERIC RET SUPER 163 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805971 N20 SPHERIC RET SUPER N20 SPHERIC RET SUPER HQA COOPERSURGICAL, INC. 163 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other