BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 9856858 · Received March 19, 2020

    Report

    Report Number
    1216677-2020-00084
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 19, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 10-07-19 UNDER WO (B)(4) AND SHIPPED ON 10/19/2019. MANUFACTURING RECORD REVIEW: DHR-252166 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 CONDITION. 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 UNITS' MAIN VALVE WAS FOUND TO HAVE BRASS SHAVINGS WHERE THE PLUNGER RESTS ON THE OPENING FOR THE LIQUID NITROGEN. THE PRESENCE OF BRASS SHAVINGS IN THIS LOCATION WILL PREVENT A SEAL ALLOWING FOR CONTINUOUS FLOW. ROOT CAUSE: THIS ISSUE HAS BEEN ADDRESSED. A THREAD WAS BEING MADE TO AN IRREGULAR MAJOR DIAMETER (ON P/N 201528) REQUIRING A RE-TAPPING OF THE 3/8 -24 THREAD. LEFT OVER SHAVINGS WERE REMOVED BUT IT IS DETERMINED A FEW UNITS MAY HAVE HAD SOME SHAVINGS THAT CAME LOOSE LATER. THE ROOT CAUSE IS BEING ATTRIBUTED TO A PRINT ERROR. THE MATING PART (201538) WAS MADE TO THE STANDARD TOLERANCES CALLED OUT FOR A 3/8-24 UNF THREAD. HOWEVER, THE IRREGULAR MAJOR DIAMETER ON P/N 201528 PREVENTS PROPER THREADING. ADDITIONALLY, THE MATING PART HAD BEEN FOUND TO HAVE THREADS HEAVILY DAMAGED FROM THE VENDOR'S PLATING SERVICE. BOTH CONDITIONS PROMPTED THE RE-TAPPING. CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS CLEANED OUT OF ANY BRASS SHAVINGS, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER UNDER WARRANTY. A QUALITY ALERT WAS PUT IN PLACE, EXPIRED 2/28/2020, TO ALERT QUALITY TO THE PRESENCE OF ANY METAL SHAVINGS. COUPLED WITH A MATING PROBLEM NOTED ON THE PRODUCTION FLOOR IT WAS DETERMINED THE SOURCE OF THE ISSUED WAS PRINT RELATED. THE VENDOR WAS PROVIDED WITH A REDLINE TO CORRECT ALL OF P/N 201528 TO OPEN UP THE MAJOR DIAMETER UNDER NCMR (B)(4) . THE PRINT WAS SUBMITTED TO ENGINEERING TO UPDATE ACCORDINGLY. ALL OF THE MATING PARTS (P/N 201538) WITH THE DAMAGED THREADS WERE RETURNED TO THAT VENDOR FOR CORRECTION, NCMR (B)(4) . NO FURTHER TRAINING REQUIRED AT THIS TIME. PREVENTATIVE ACTION ACTIVITY REFERENCE NCMR (B)(4) AND NMCR (B)(4) . COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "LEAKING LIQUID NITROGEN SPRAYER THAT HAS REACHED END OF LIFE" REFERENCE REPAIR ORDER (B)(4). REF E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "LEAKING LIQUID NITROGEN SPRAYER THAT HAS REACHED END OF LIFE". REFERENCE REPAIR ORDER #: (B)(4). REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321611 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other