BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 12222993 · Received July 25, 2021

    Report

    Report Number
    1216677-2021-00149
    Event Type
    Malfunction
    Date Received
    July 25, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 25, 2021
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS. COMPLAINT (B)(4). WAS THE COMPLAINT CONFIRMED? YES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 01/17/2013 UNDER WO #(B)(4) AND SHIPPED ON 02/07/2013. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. 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 NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE UNIT WAS CONFIRMED TO HAVE LOST VACUUM AND CONSISTENT WITH THE PROBLEM DESCRIPTION DUE TO THE RAPID LOSS OF LIQUID NITROGEN. THE LOSS OF VACUUM INDICATES THE UNIT WAS IMPACTED IN SOME MANNER LIKELY DROPPED. THE LOSS OF VACUUM RESULTS IN THE LOSS OF INSULATION THEREBY RESULTING IN THE RAPID EVAPORATION OF N2O. ROOT CAUSE IS BEING ATTRIBUTED TO HANDLING ERROR. *CORRECTION AND/OR CORRECTIVE ACTION. THE UNIT WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED. PREVENTATIVE ACTION ACTIVITY. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED FROSTING AND EVAPORATION OF LN2. REPAIR TECH STATED "CONFIRMED, BOTTLE LOST VACUUM". RO 86601. PER RISK DOCUMENTATION, FROST ON BOTTLE IS RISK 8. WALLACH ULTRA FREEZE 900076 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED FROSTING AND EVAPORATION OF LN2. REPAIR TECH STATED "CONFIRMED, BOTTLE LOST VACUUM". RO 86601 PER RISK DOCUMENTATION, FROST ON BOTTLE IS RISK 8. WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119764 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O