BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 13663850 · Received March 3, 2022

    Report

    Report Number
    1216677-2022-00058
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    January 20, 2022
    Report Date
    March 3, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. X-REVIEW DHR X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 09/01/2015 UNDER WO #172173 AND SHIPPED ON 10/07/2015. MANUFACTURING RECORD REVIEW: DHR 172173 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 APRIL 2016 FOR A BOTTLE THAT HAD LOST ITS VACUUM SEAL. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON REPAIR LOG 97786. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE TO THE TRIGGER. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE BROKEN TRIGGER IS BEING ATTRIBUTED TO HANDLING ERROR BY THE END USER. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER. NO FURTHER CORRECTIVE ACTION IS NECESSARY. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    BROKEN HANDLE. CONFIRMED COMPLAINT: TRIGGER BROKEN OFF. REPAIR ORDER 97786. WALLACH ULTRA FREEZE 900076 E-COMPLAINT(B)(4).

    Description of Event or Problem · 0

    BROKEN HANDLE. CONFIRMED COMPLAINT: TRIGGER BROKEN OFF. REPAIR ORDER 97786. 1216677-2022-00058 WALLACH ULTRA FREEZE 900076 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899949 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other