BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 13341092 · Received January 25, 2022

    Report

    Report Number
    1216677-2022-00011
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    November 8, 2021
    Report Date
    March 23, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW DHR: INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: COMPLAINT: (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 07/25/2017 UNDER WO#: (B)(4) AND SHIPPED ON 10/03/2017. MANUFACTURING RECORD REVIEW: DHR 211868 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED IN 2019 FOR A BROKEN TRIGGER. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED WEAR DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: A DEFINITIVE ROOT CAUSE IS NOT DETERMINED. HOWEVER, BASED ON THE OBSERVED WEAR A ROOT CAUSE IS POTENTIALLY DUE TO WEAR AND TEAR FROM HEAVY USAGE. THE TRAPPED MOISTURE MAY INDICATE POOR HANDLING AS WELL. CORRECTIVE ACTIONS: THE CUSTOMER REQUESTED THE UNIT BE SCRAPPED OUT AT CSI. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO TRAINING REQUIRED. WAS THE COMPLAINT CONFIRMED? YES.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    NITROGEN IS LEAKING FROM VALVE. CONFIRMED COMPLAINT: BOTH MAIN AND RELIEF VALVES WORN AND LEAKING. ENTIRE UNIT AND INSIDE OF BOTTLE IS WET. REPAIR ORDER: (B)(4). FROM S&R: MAIN VALVE LEAK MEANS USER CANNOT CONTROL FLOW. RELIEF VALVE LEAK IS INTERNAL, DOES NOT AFFECT PATIENT OR USER. 1216677-2022-00011-1 WALLACH ULTRA FREEZE 900076 E-COMPLAINT: (B)(4).

    Description of Event or Problem · 0

    NITROGEN IS LEAKING FROM VALVE CONFIRMED COMPLAINT: BOTH MAIN AND RELIEF VALVES WORN AND LEAKING. ENTIRE UNIT AND INSIDE OF BOTTLE IS WET. REPAIR ORDER 97466 FROM S&R: MAIN VALVE LEAK MEANS USER CANNOT CONTROL FLOW. RELIEF VALVE LEAK IS INTERNAL, DOES NOT AFFECT PATIENT OR USER. WALLACH ULTRA FREEZE 900076 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596682 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other