BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 17610629 · Received August 24, 2023

    Report

    Report Number
    1216677-2023-00120
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 4, 2023
    Report Date
    September 21, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010961
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 06-25-21 UNDER WORK ORDER (B)(4) AND SOLD ON 01-AUG-2021. MANUFACTURING RECORD REVIEW: (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. 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 100748 THIS UNIT WAS AT CSI ON 08-AUG-2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. THE BOTTLE RETURNED WITH THE UNIT IS FROM A DIFFERENT UNIT (SERIAL NUMBER (B)(6). FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE MAIN VALVE STEM/SEAL BEING MISSHAPED. THIS ISSUE IS BEING ATTRIBUTED TO THE VALVE STEM/SEAL BEING OVER CRIMPED IN THE ASSEMBLY PROCESS. THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE VALVE STEM WAS REPLACED. THE UNIT WAS TESTED AND FOUND TO BE ACCEPTABLE. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. THE OPERATORS WERE RETRAINED TO THE PROCEDURE.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE FREEZING SPOTS, THE LEVER KEPT STICKING. NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. 900076 ULTRA 2023-08-0000163.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56589 WALLACH ULTRA FREEZE GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL GEH COOPERSURGICAL, INC. 900076 N/A 00888937010961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown