BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 17606960 · Received August 23, 2023

    Report

    Report Number
    1216677-2023-00121
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 9, 2023
    Report Date
    October 19, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010961
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 10-NOV-2022 UNDER WORK ORDER (B)(4)AND THE SHIP DATE IS NOT KNOWN. MANUFACTURING RECORD REVIEW: DHR-322386 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 (B)(4) THIS UNIT WAS AT CSI ON 18-AUG-2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THERE IS A DENT IN THE BOTTLE ALONG THE TOP EDGE. THE VACUUM OF THE BOTTLE IS OK. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. LEAKING. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE DIP TUBE GETTING SLIGHTLY BENT BY THE CUSTOMER. THIS THEN CAUSED THE END OF THE DIP TUBE TO CONTACT THE BOTTOM OF THE CANNISTER WHICH PREVENTED THE CANNISTER CAP TO BE ABLE TO BE CLOSED COMPLETELY AND CAUSED THE LEAKAGE. THE DIP TUBE WAS ADJUSTED AND THE UNIT WAS TESTED OK TO FORM-PROD 282. THE UNIT WAS RELEASED FOR SHIPPING IT BACK TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    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 LIQUID NITROGEN LEAKS OUT EVEN WITH LID SECURELY CLOSED. NO ADVERSE EVENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 900076 ULTRA 2023-08-0000337.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497750 WALLACH ULTRA FREEZE GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL GEH COOPERSURGICAL, INC. 900076 N/A 00888937010961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown