BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 15779938 · Received November 11, 2022

    Report

    Report Number
    1216677-2022-00289
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 14, 2022
    Report Date
    January 19, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010961
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    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 09-JUN-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: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. 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. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. AS A PRECAUTION THE TRIGGER HINGE PIN WAS CLEANED. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    FREEZING UP. BOTH PINS LOOK RUSTY. SPARE PIN IS ALSO RUSTY. FS LOG # (B)(4). WALLACH ULTRA FREEZE 900076 (B)(4).

    Description of Event or Problem · 0

    FREEZING UP. BOTH PINS LOOK RUSTY. SPARE PIN IS ALSO RUSTY. FS LOG # (B)(4). WALLACH ULTRA FREEZE 900076 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    FREEZING UP. BOTH PINS LOOK RUSTY. SPARE PIN IS ALSO RUSTY. 1216677-2022-00289-2 WALLACH ULTRA FREEZE 900076 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2789754 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A 00888937010961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other