BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 MULTI TIP W/TC

    MDR report key: 17442500 · Received August 2, 2023

    Report

    Report Number
    1216677-2023-00110
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 24, 2023
    Report Date
    October 3, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    888937009866
    PMA / PMN Number
    K813024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 03/09/2017 UNDER WO #(B)(4) AND SHIPPED ON 04/19/2017. MANUFACTURING RECORD REVIEW: DHR 196995 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 ONE OTHER REPORTED COMPLAINT CONDITION, BUT FROM THE SAME CUSTOMER SENT AT THE SAME TIME AS THIS UNIT. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 100695, THIS UNIT WAS AT CSI ON 07/27/2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: IT WAS DETERMINED ATTEMPTS TO REPAIR THE UNIT BY THE CUSTOMER OR AN OUTSIDE SERVICE CONTRIBUTED TO THE DAMAGE. A ROOT CAUSE IS NOT POSSIBLE DUE TO THE DAMAGE, BUT END USER HANDLING IS CONSIDERED A CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS SENT FOR REPAIR DUE TO A LEAK. NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 900629 (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385065 LL100 MULTI TIP W/TC GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL GEH COOPERSURGICAL, INC. 900629 N/A 888937009866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown