BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR

    MDR report key: 1741220 · Received June 29, 2010

    Report

    Report Number
    2084725-2010-00237
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 11, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K040883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURE DATE: 12/2008. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, FAILURE MODE EFFECTS ANALYSIS, THE HEALTH HAZARD EVALUATION, SYSTEM HAZARD USE AND MISUSE ANALYSIS, FAILURE MODE EFFECTS ANALYSIS AND THE HEALTH HAZARD EVALUATION. THE DHR FOR THE EVOTECH WAS REVIEWED AND NO ISSUES WERE NOTED. THE SERVICE AND COMPLAINT HISTORY FOR THE EVOTECH ENDOSCOPIC CLEANER AND REPROCESSOR WAS REVIEWED FOR SIX MONTHS AND THERE WAS NO SIMILAR ISSUE WITH THE UNIT. TRENDING ANALYSIS FOR "ODOR/SMELLS" WAS COMPLETED FOR (B)(6) 2010 THROUGH (B)(6) 2011 AND THERE IS NOT A SIGNIFICANT TREND. THE SHUMA (SYSTEM HAZARD USE AND MISUSE ANALYSIS) WAS REVIEWED AND THE ASSOCIATED RISK IS "AS LOW AS REASONABLY PRACTICABLE". THE FMEA (FAILURE MODE EFFECTS ANALYSIS) WAS REVIEWED AND FOUND THAT ALL RELATED FAILURE MODES HAVE OVERALL RISK NUMBERS BELOW 100. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED AND THE RISK ASSOCIATED IS NOT SIGNIFICANT TO CAUSE ANY HEALTH HAZARD TO A USER OR A PERSON AROUND THE UNIT. A SCAR (SUPPLIER CORRECTIVE ACTION REPORT) WAS INITIATED FOR THIS ISSUE. PARTS WERE RETURNED TO THE SUPPLIER FOR INVESTIGATION. IT WAS DISCOVERED THAT THE LIKELY CAUSE OF THE ISSUE WAS DUE TO OVER TIGHTENING DURING INSTALLATION OF THE SYSTEM. THE SUPPLIER RECOMMENDED A FEW ACTIONS, INCLUDING LIMITING THE CURRENT TO THE SENSOR, WHICH WOULD PREVENT A REOCCURRENCE OF THIS ISSUE. CHANGE ORDERS WERE CREATED IN ORDER TO RELEASE A NEW ADAPTER HARNESS ASSEMBLY THAT WOULD LIMIT THE CURRENT THROUGH THE DRIP TRAY SENSOR CONNECTOR.

    Additional Manufacturer Narrative · 1

    EVALUATED BY MFG: AN ASP FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT. THE FSE REPAIRED THE UNIT, RAN A NULL OFFSET CYCLE, TEST CYCLES, AND A SELF DISINFECT CYCLE WITH NO ISSUES AFTER SERVICE. THE FSE STATED THAT THE DEFECTIVE PARTS WILL BE RETURNED FOR INVESTIGATION. AN INVESTIGATION WILL BE PERFORMED ON ANY PRODUCT RETURNED, AND ANY ADDITIONAL INFORMATION OBTAINED WILL BE SUBMITTED IN A SUPPLEMENTAL MEDWATCH REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ONE DAY FOLLOWING A PREVENTIVE MAINTENANCE, THE EVOTECH SYSTEM CAUGHT ON FIRE AND WAS SMOKING. THERE WAS NO REPORT OF INJURY OR HARM DUE TO THIS INCIDENT. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR EVOTECH EQUIPMENT FEB ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1