BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 8883185 · Received August 12, 2019

    Report

    Report Number
    1216677-2019-00222
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    March 21, 2019
    Report Date
    December 18, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE E-COMPLAINT - (B)(4). INVESTIGATION: X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: COMPLAINT # (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 7/25/17 UNDER WO # (B)(4) AND SHIPPED ON 10/17/17. 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: ONE ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT UNDER LOG 90452 FOR BLOCKAGE IN THE NOZZLE 11/1/2018. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE ATTACHED 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. THE VERY SAME UNIT HAD COME IN FOR BLOCKAGE. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED UNDER WARRANTY. HOWEVER, BASED ON LOG 91654, THIS UNIT WAS AT CSI ON 3/21/2019. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT. ROOT CAUSE : WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE DUE TO END USER ERROR. THE FIRST COMPLAINT WAS BLOCKAGE DUE TO FOREIGN MATERIAL MAKING ITS WAY INTO THE DEVICE. IT IS LIKELY THE DEWAR THE CUSTOMER IS USING TO REFILL THE DEVICE HAS PARTICULATES TRANSFERRED TO THE BOTTLE. ASSEMBLY ERROR IS NOT CONSIDERED A POTENTIAL ROOT CAUSE AS THIS DEVICE HAD PASSED THE INITIAL IN-PROCESS TESTING IN 2017 AND CHECKED OUT AGAIN IN 2018. CORRECTION AND/OR CORRECTIVE ACTION: THIS DEVICE WAS CLEARED OF THE DEBRIS, TESTED TO SPECIFICATION AND RETURNED TO THE CUSTOMER UNDER WARRANTY. PRODUCTION WAS MADE AWARE OF THE COMPLAINT AND PRODUCED AN UPDATED TRAINING RECORD. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS. WAS THE COMPLAINT CONFIRMED? YES. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    REPAIR STATED "VALVE STAYS OPEN AND UNIT CONTINUOUSLY SPRAYS." REFERENCE REPAIR ORDER # (B)(4). REFERENCE: E-COMPLAINT - (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION PROCESS IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REPAIR STATED "VALVE STAYS OPEN AND UNIT CONTINUOUSLY SPRAYS" REFERENCE REPAIR ORDER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679127 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other