BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 15287065 · Received August 24, 2022

    Report

    Report Number
    1216677-2022-00245
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    August 5, 2022
    Report Date
    October 24, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 2022-08-0000259. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 03/17/2019 UNDER WORK ORDER 248286 AND SOLD ON 09/05/2019. MANUFACTURING RECORD REVIEW: DHR-248286 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 98935 THIS UNIT WAS AT CSI ON 08/11/2022. 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. IT WAS NOTED DURING THE EVALUATION THAT THE APERTURE WAS BLOCKED. THE BLOCKAGE WAS CLEARED. THIS ISSUE COULD HAVE MADE IT SEEM LIKE THE UNIT WAS NOT FUNCTIONING PROPERLY. THE BLOCKAGE WAS MOST LIKELY A SMALL PIECE OF DEBRIS THAT CAME FROM THE DEWAR CANNISTER. THE CUSTOMER MOST LIKELY IS NOT CLEANING THEIR DEWAR CANNISTER AS FREQUENTLY AS THEY SHOULD BE. *CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. THE BLOCKAGE WAS CLEARED IN THE APERTURE. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    BROKEN VALVE BLACK TOP SPRAY PIECE END LEAKING. NOT WORKING PROPERLY. FS LOG # (B)(4). WALLACH ULTRA FREEZE 900076 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    BROKEN VALVE BLACK TOP SPRAY PIECE END LEAKING. NOT WORKING PROPERLY. FS LOG # 98935. 1216677-2022-00245 WALLACH ULTRA FREEZE 900076 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828333 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other