BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 5575707 · Received April 13, 2016

    Report

    Report Number
    2084725-2016-00210
    Event Type
    Malfunction
    Date Received
    April 13, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) USER SELECTED INCORRECT CYCLE TO PROCESS LOAD.

    Additional Manufacturer Narrative · 1

    CORRECTION TO DEVICE EVALUATED BY MFR?: ASP INVESTIGATION SUMMARY. THE CORRECT STATEMENT IS "ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SYSTEM RISK ANALYSIS (SRA)."

    Additional Manufacturer Narrative · 1

    CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED BY THE CUSTOMER STATING IT WAS NOT A BATTERY THAT WAS NOT RECALLED FROM THE AFFECTED LOAD, BUT A SHIKANI SCOPE. THE SHIKANI SCOPE (MANUFACTURED BY CLARUS MEDICAL, LLC) IS VALIDATED FOR ONLY THE STANDARD CYCLE IN THE STERRAD® NX UNIT. (B)(4). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), PRODUCT RETURN AND SYSTEM RISK ANALYSIS (SRA). THE DHR WAS REVIEWED AND NO ISSUES RELATING THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. THE SRA INDICATES THE RISK ASSOCIATED WITH EXPOSURE TO BIOHAZARDOUS, PATHOGENIC OR INFECTIOUS MATERIAL IS "LOW." THE ASSIGNABLE CAUSE WAS USER ERROR. THE ASP ACCOUNT MANAGER MET WITH THE CUSTOMER TO INQUIRE AND OFFER ADDITIONAL TRAINING REGARDING THE ISSUE. THE CUSTOMER DECLINED ADDITIONAL EDUCATION/IN-SERVICE AND INDICATED THAT TRAINING WAS TAKEN CARE OF INTERNALLY. THE ISSUES WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE KARL STORZ HEART SCOPE AND CAMERA WERE PROCESSED IN THE ADVANCED CYCLE WHEN IT SHOULD HAVE BEEN PROCESSED IN THE STANDARD CYCLE IN THE STERRAD NX. THE CUSTOMER WAS ABLE TO RECALL ALL ITEMS IN THE LOAD EXCEPT A BATTERY. THERE IS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THIS EVENT IS REPORTED TO THE FDA SINCE THE LOAD WAS NOT PROCESSED IN THE CORRECT CYCLE AND WAS PARTIALLY RELEASED AND USED ON A PATIENT(S). ASP WILL CONTINUE TO FOLLOW UP FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228857 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1