BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 CATARACT PRB STRT

    MDR report key: 11569989 · Received March 25, 2021

    Report

    Report Number
    1216677-2021-00051
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 16, 2021
    Report Date
    January 27, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    UDI-DI
    00888937004212
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INSPECT RETURNED SAMPLES DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN 1984. 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: 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 ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: ALTHOUGH THE UNIT FUNCTIONED THE END/TIP WAS DAMAGED AS IF DROPPED ON THE FLOOR. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO END USER HANDLING ERROR. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS 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. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    CUSTOMER STATED: "LEAK". 1216677-2021-00051-1 126 N20 CATARACT PRB STRT (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    E-COMPLAINT: (B)(4). CUSTOMER STATED "LEAK". REPAIR TECH STATED "LEAK LE FOUND, MFG JUNE 1984, BOILER TIP IS SHARP, NO LEAKS FOUND - FILED TIP SMOOTH & POLISHED". FOLLOW-UP WITH REPAIR TECH "THE BOILER TIP TOUCHES THE EYE, SHARP RISKS INJURY TO THE PATIENTS EYE, THEY ARE SILVER SO THEY DEFORM IF PINCHED OR DROPPED THIS ONE LOOKED DROPPED" REPAIR ORDER 95785 N20 CATARACT PRB STRT 126 E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469813 N20 CATARACT PRB STRT N20 CATARACT PRB STRT HQA COOPERSURGICAL, INC. 126 N/A 00888937004212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other