BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 17299007 · Received July 11, 2023

    Report

    Report Number
    1216677-2023-00102
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 30, 2023
    Report Date
    July 27, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010961
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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 21-NOV-2017 UNDER WORK ORDER (B)(4) AND SOLD ON 09-JAN-2018. MANUFACTURING RECORD REVIEW: DHR-220870 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: 04-OCT-2022 - (B)(4)-BAD SEALS AND TRIGGER-THE DELIVERY TUBE IS TOO LONG. THE DELIVERY TUBE WAS SHORTENED. TESTED OK. 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 06-JUL-2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. 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 BEING WORN AND CORRODED. THIS ISSUE IS BE ATTRIBUTED TO NORMAL WEAR AND TEAR. THE VALVE ASSEMBLY WAS CLEANED AND ADJUSTED. THE UNIT WAS TESTED OK AND WAS RETURNED 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 THE VALVE WOULD NOT CLOSE DURING CRYOSURGERY. NO ADVERSE EVENT. NO ADDITIONAL INFORMATION. 1216677-2023-00102 900076 ULTRA FREEZE 2023-07-0000128.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193666 WALLACH ULTRA FREEZE GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL GEH COOPERSURGICAL, INC. 900076 2017110055 00888937010961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown