BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 15360480 · Received September 6, 2022

    Report

    Report Number
    1216677-2022-00252
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 12, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 25-JUN-2021 UNDER WORK ORDER (B)(4) AND SOLD ON 09-AUG-2021. MANUFACTURING RECORD REVIEW: DHR-298440 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. HOWEVER, BASED ON LOG (B)(4) UNIT IT WAS AT CSI ON 22-AUG-2022. 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. THE UNIT WAS TESTED AND FOUND TO BE FUNCTIONING PROPERLY. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    NO LONGER WORKING. UNCONTROLLED NITROGEN SPRAY. FS LOG#: 98992. WALLACH ULTRA FREEZE 900076 E-COMPLAINT-2022-08-0000412.

    Description of Event or Problem · 0

    NO LONGER WORKING. UNCONTROLLED NITROGEN SPRAY. FS LOG # (B)(4). 1216677-2022-00252 WALLACH ULTRA FREEZE 900076 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269364 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other