BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 9341982 · Received November 19, 2019

    Report

    Report Number
    1216677-2019-00297
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    October 22, 2019
    Report Date
    December 27, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE E-COMPLAINT (B)(4). ANALYSIS AND FINDINGS DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON (B)(6) 2019 UNDER WO (B)(4) AND SHIPPED ON (B)(6) 2019. MANUFACTURING RECORD REVIEW: DHR (B)(4) 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 ATTACHED 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 (B)(6) 2019. 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 (B)(4). CORRECTIVE ACTIONS. CORRECTION AND OR CORRECTIVE ACTION ALL PARTS (P/N (B)(4) WERE RETURNED TO THE VENDOR FOR CORRECTION UNDER NCMR (B)(4). A QUALITY ALERT REMAINS IN PLACE TO CHECK FOR BRASS CHIPS OR SHAVINGS AS WELL. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES. PREVENTATIVE ACTION ACTIVITY. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "CONSTANTLY SPRAYS" REFERENCE REPAIR ORDER #(B)(4). REF E COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION PROCESS IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED "CONSTANTLY SPRAYS". REFERENCE REPAIR ORDER #: (B)(4). REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140141 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other