BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 9369424 · Received November 25, 2019

    Report

    Report Number
    1216677-2019-00303
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 25, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION : X-REVIEW DHR : X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS : COMPLAINT (B)(4). WAS THE COMPLAINT CONFIRMED? YES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 1/1/19 UNDER WO #(B)(4) AND SHIPPED ON 6/6/19. MANUFACTURING RECORD REVIEW: DHR 237677 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT DID NOT SPRAY NORMALLY DUE TO BRASS SHAVINGS OBSTRUCTING THE FLOW OF N2O. ROOT CAUSE: THE SOURCE OF THE METALS SHAVINGS IS NOT DEFINITIVELY DETERMINED. HOWEVER, ASSEMBLERS HAVE BEEN NOTED TO TAP THE THREADS INTO P/N 201528 DUE TO AN LEAD IN ERROR ON THE THREADS. THE SOURCE OF THE BRASS CHIPS IS CONSIDERED TO BE AT ASSEMBLY DUE TO A NON-CONFORMITY ON P/N 201528. CORRECTIVE ACTIONS: CORRECTION AND/OR CORRECTIVE ACTION : ALL PARTS (P/N 201528) WERE RETURNED TO THE VENDOR FOR CORRECTION UNDER NCMR 12743. A QUALITY ALERT REMAINS IN PLACE TO CHECK FOR BRASS CHIPS OR SHAVINGS AS WELL. NO FURTHER TRAINING REQUIRED AT THIS TIME. PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "CONTINUOUS SPRAY". REFERENCE REPAIR ORDER #(B)(4). REF (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "CONTINUOUS SPRAY". REFERENCE REPAIR ORDER #: (B)(4). REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168197 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other