BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 8749742 · Received July 1, 2019

    Report

    Report Number
    1216677-2019-00188
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    May 21, 2019
    Report Date
    December 17, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE (B)(4). X-INVESTIGATION, X-INSPECT RETURNED SAMPLES, ANALYSIS AND FINDINGS THE COMPLAINT UNIT, SERIAL # (B)(4), WAS MANUFACTURED AND SHIPPED IN APRIL OF 2019. A REVIEW OF THE 2 YEAR COMPLAINT HISTORY FOR THE WALLACH ULTRA FREEZE, ITEM #900076, SHOWS SIMILAR REPORTED COMPLAINT CONDITIONS. DHR-900076-248287 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. PER REPAIR AUTHORIZATION: "AS PER CUSTOMER TRIGGER STAYS ON, ALL NITROGEN SPRAYS OUT." AS PER REPAIR ORDER 92099: THE REPAIR TECH FOUND BRASS CHIPS AND SHAVINGS FROM THE RELIEF DEVICE CAUGHT IN THE MAIN VALVE; PREVENTING IT FROM CLOSING. THE COMPLAINT UNIT WAS REPAIRED AND TESTED TO FORM-PROD 282. THE COMPLAINT WAS CONFIRMED AFTER EVALUATION. PER SERVICE AND REPAIR, THIS WAS POSSIBLY AN ASSEMBLY ERROR. THE ASSEMBLY ERROR IS THE MOST PROBABLE ROOT CAUSE GIVEN WHAT WAS FOUND ON THE COMPLAINT UNIT. HOWEVER, THESE DEVICES ARE 100% INSPECTED PRIOR TO RELEASE. THE FAILED UNIT WAS CONFIRMED TO HAVE PASSED THE IN-PROCESS CHECKS. THE SUPERVISOR, OPERATIONS WAS NOTIFIED AND THE ASSEMBLER WAS RETRAINED ON THE ASSEMBLY METHOD (WALLACH ULTRAFREEZE ASSEMBLY - 300760-300764-MS). IN ADDITION, THE ASSEMBLY WAS NOTIFIED TO BE ATTENTIVE TO THE PRESENCE OF BURRS ON THE BRASS PART, P/N 201528. THERE IS, ALSO, A QUALITY ALERT ASSOCIATED WITH THIS ISSUE FOR P/N 201528, THREAD. ADAPT. ULTRAFREEZE. THIS PART IS A THREAD ADAPTOR WHICH THE RELIEF DEVICE ATTACHES TO. THE QUALITY ALERT WARN OF BURRS ON THE THREADS. THESE BURRS ARE, LIKELY, THE SOURCE OF THE BRASS CHIPS AND SHAVINGS WHICH CAUSED THIS COMPLAINT. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. CORRECTION AND/OR CORRECTIVE ACTION THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE ASSEMBLER WAS RETRAINED ON THE ASSEMBLY METHOD (WALLACH ULTRAFREEZE ASSEMBLY 300760-300764-MS). A QUALITY ALERT HAS BEEN CREATED AND POSTED AT THE WORK STATIONS WHERE THE WALLACH ULTRAFREEZES ARE BUILT, WARNING OF BURRS ON THE THREAD. ADAPT. ULTRAFREEZE, P/N 201528. ALSO, AS PER THE QUALITY ENGINEER, THE VENDOR FOR P/N 201528 HAS BEEN NOTIFIED OF THIS ISSUE WITH THE BURRS. THIS COMPLAINT WILL BE ENTERED INTO THE COOPERSURGICAL CONTINUOUS IMPROVEMENT PROGRAM (CIP). NO FURTHER CORRECTIVE ACTIONS ARE REQUIRES 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: AS PER CUSTOMER TRIGGER STAYS ON, ALL NITROGEN SPRAYS OUT. REFERENCE REPAIR LOG (B)(4). REF: (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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED: AS PER CUSTOMER TRIGGER STAYS ON, ALL NITROGEN SPRAYS OUT. REFERENCE REPAIR LOG 92099. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545147 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other