BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 11777612 · Received May 5, 2021

    Report

    Report Number
    1216677-2021-00079
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 5, 2021
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-INSPECT RETURNED SAMPLES ANALYSIS AND FINDINGS . COMPLAINT (B)(4). WAS THE COMPLAINT CONFIRMED? NO. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 01/03/2018 UNDER WO (B)(4) AND SHIPPED ON 03/22/2018. 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 ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED UNDER WARRANTY. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: THE PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS TESTED TO SPECIFICATIONS WITH NO FUNCTIONAL DEFECTS NOTED AND RETURNED TO THE CUSTOMER UNDER WARRANTY. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "DOES NOT SPRAY CRYO" REPAIR TECH STATED "CANNOT VERIFY" RO (B)(4). 1216677-2021-00079 WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "DOES NOT SPRAY CRYO" REPAIR TECH STATED "CANNOT VERIFY". (B)(4). WALLACH ULTRA FREEZE 900076 E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675475 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O