BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1395930 · Received May 26, 2009

    Report

    Report Number
    2084725-2009-00321
    Event Type
    Malfunction
    Date Received
    May 26, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 29, 2009
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MDR#: 2084725-2009-00324.

    Additional Manufacturer Narrative · 1

    THIS IS ASP'S ASSESSMENT OF A REPORT RECEIVED DURING A CLINICAL EDUCATION CONSULTANT (CEC) VISIT TO A (B)(6) MEDICAL CENTER. THE CUSTOMER STATED THAT THE STERRAD IS CAUSING THE LENS IN THEIR SCOPES TO TURN FOGGY AND UNCLEAR. THE CUSTOMER STATED THE SCOPES ARE APPROVED FOR USE WITH THE STERRAD SYSTEM. THE CEC ASSOCIATE EXPLAINED TO CUSTOMER THAT THEY NEED TO CHECK ON THE DECONTAMINATION PROCESS THAT THE ORERATING ROOM IS DOING BEFORE THEY SEND THE SCOPES DOWN FOR PROCESSING. THE CUSTOMER STATED DURING FOLLOW-UP, THAT IT WAS POSSIBLE THAT DURING THE OPERATION, THE SCOPE WAS DAMAGED, CAUSING MOISTURE TO LEAK THROUGH THE SEAL OF THE SCOPE. THEY ARE UNCERTAIN AS TO WHAT CAUSED THE LENS TO BE FOGGY OR UNCLEAR. THERE WERE NO PATIENTS OR INJURIES INVOLVED. BECAUSE THE CATALOG #S OF THE SCOPES ARE UNKNOWN, A STERRAD STERILITY GUIDE COMPATIBILITY SEARCH COULD NOT BE DONE TO CONFIRM WHETHER THE SCOPES WERE COMPATIBLE WITH THE SYSTEM. FOR THE STERRAD NX UNIT, SERIAL # (B)(4), THIS IS THE ONLY DAMAGED DEVICE COMPLAINT AT THE TIME OF THE REPORT. NO PARTS OF THE STERRAD NX UNIT WERE RETURNED OR REPLACED ACCORDING TO THE SERVICE ORDER HISTORY FOR THE UNIT. THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT WAS REVIEWED AND THERE WERE NO INDICATIONS OF ANY ISSUES. THERE HAVE NOT BEEN ANY RELATED COMPLAINTS FOR THE STERRAD NX SERIAL # (B)(4) SINCE THIS COMPLAINT. (B)(4). THE STERRAD NX DEFECTS PER MILLION OPPORTUNITIES (DPMO) CHART INDICATES THAT THERE IS NO INCREASING TREND FOR THE PROBLEM CODE "DAMAGE TO CUSTOMER DEVICE" AND (B)(4). THREE UNSUCCESSFUL ATTEMPTS WERE MADE TO THE CUSTOMER TO OBTAIN MORE INFORMATION AND HAVE THEM COMPLETE THE ASP DAMAGED DEVICE WORKSHEET. WITHOUT INFORMATION SUCH AS THE MODELS OF THE SCOPES USED AND OTHER DETAILS FROM THIS WORKSHEET, THIS ISSUE CANNOT BE INVESTIGATED FURTHER. ASP WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THEY HAVE BEEN GETTING COMPLAINTS FROM THE OPERATING ROOM THAT THE STERRAD IS CAUSING THE LENS IN THEIR SCOPES TO TURN FOGGY AND UNCLEAR. THE ASP CLINICAL EDUCATION CONSULTANT (CEC) EXPLAINED TO THE CUSTOMER THAT SHE NEEDS TO CHECK ON THE DECONTAMINATION PROCESS THAT THE OPERATING ROOM IS DOING BEFORE THEY SEND THE SCOPES DOWN FOR PROCESSING. THE OPERATING ROOM DIRECTOR CLAIMS THAT BOTH THE ST200 AND THE STNX ARE CAUSING DAMAGE TO THEIR SCOPES. THE CUSTOMER SPOKE WITH THE DEVICE MFR AND CONFIRMED SCOPE COMPATIBILITY WITH THE NX. THE CUSTOMER STATED THE FOLLOWING: PERHAPS MOISTURE LEAKED THROUGH THE SEAL; A POSSIBILITY THAT DURING THE OPERATING PROCEDURE, THE DEVICE WAS DAMAGED CAUSING MOISTURE TO LEAK THROUGH THE SEAL; THERE WAS NO CANCELLATION DURING THE CYCLE; FOLLOWED THEIR USUAL CLEANING PROCEDURE; AFTER IT WAS STERILIZED, OPERATING ROOM STAFF OPENED THE WRAPPED DEVICE AND REPORTED THE LENS AS UNCLEAR/FOGGY. AT THIS TIME IT IS UNSURE WHAT CAUSED THE LENS TO BE FOGGY OR UNCLEAR. CUSTOMER INDICATED THERE WERE NO PT INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ACMI