BEUDAMED
    FDA Adverse Event Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 2021918 · Received March 17, 2011

    Report

    Report Number
    2150060-2011-00016
    Date Received
    March 17, 2011
    Date of Event
    October 1, 2010
    Report Date
    March 9, 2011
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ASP PROVIDES ALL MAINTENANCE AND TECHNICAL SUPPORT FOR THIS DEVICE. ADVANCED STERILIZATION PRODUCTS(ASP), CO-MANUFACTURER, PROVIDES ALL MAINTENANCE AND TECHNICAL SUPPORT FOR THIS DEVICE. ASP IS EVALUATING THIS INCIDENT AND WILL RESOLVE/CORRECT THE PROBLEM. IN ADDITION TO THIS MDR, AN MDR HAS BEEN FILED BY ASP UNDER MINNTECH'S NAME AND ESTABLISHMENT NUMBER. NO KNOWN PATIENT INJURY HAS BEEN REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, MINNTECH WILL REVIEW UPON RECEIPT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED IMPROPER PROCESSING TIME IN UNIT. THE UNIT WAS NOT SET FOR DISINFECTING 12 MINUTES. IT IS REPORTED THIS PROCESSING ERROR BEGAN IN (B)(6) 2010. THE CUSTOMER WAS ADVISED THAT THE TIME PROGRAMMED FOR DISINFECT RELATES TO THE PRODUCT BEING USED TO DISINFECT (I.E. CIDEX OPA). THE CUSTOMER WAS ADVISED TO FOLLOW THE DISINFECTANT INSTRUCTIONS FOR USE. IT WAS CONFIRMED THAT THE CORRECT DISINFECT PROCESSING TIME HAS BEEN SET. IT IS UNKNOWN HOW MANY PATIENTS HAD PROCEDURES WITH SCOPES THAT WERE NOT PROCESSED AT THE CORRECT HLD (HIGH LEVEL DISINFECT) TIME. IT WAS REPORTED THAT THERE HAVE BEEN NO PATIENT REPORTS OF INJURY OR HARM. THIS FACILITY HAS TWO AER UNITS. THIS IS REPORT ONE OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPIC DISINFECTANT FEB MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 CIDEX OPA