BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 16708943 · Received April 10, 2023

    Report

    Report Number
    1216677-2023-00060
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    February 10, 2023
    Report Date
    May 25, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010961
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 01-MAY-2017 UNDER WORK ORDER (B)(4) AND SOLD ON 30-MAY-2017. MANUFACTURING RECORD REVIEW: DHR-211866 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: 08-JAN-2018 - 87811-NOT HOLDING PRESSURE-NO ISSUES FOUND WITH THE UNIT-TESTED OK. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4) THIS UNIT WAS AT CSI ON 20-MAR-2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE LUER LOCK IS BENT POSSIBLY FORM BEING DROPPED. THE BOTTLE RETURNED (2021070008) IS FROM A DIFFERENT UNIT. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO NOT FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE BOTTLE THAT HAS LOST VACUUM AND THE LUER LOCK BEING BENT. IT APPEARS TO THE TECHNICIAN THAT THE UNIT WAS DROPPED. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. THE CUSTOMER HAS DECIDED TO NOT HAVE THE UNIT REPAIRED. THE UNIT HAS BEEN SCRAPPED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? YES.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    BOTTLE FREEZES ON THE OUTSIDE, WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    AS PER DETAILS REPORTED ON E-COMPLAINT (B)(4) FROM FS LOG # 100090. CRYOSURGICAL SYSTEM BOTTLE FREEZES ON THE OUTSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911464 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A 00888937010961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other