BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1942962 · Received December 30, 2010

    Report

    Report Number
    2084725-2010-00318
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: STRYKER 1188 HD CAMERAS (3) - PART AND SERIAL NUMBERS UNKNOWN. HARMONIC SCALPEL - PART AND SERIAL NUMBER UNKNOWN. STRYKER 1088 HD CAMERAS (2) - PART AND SERIAL NUMBERS UNKNOWN. (B)(4) - SUSPECT POSITIVE BI.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: STERRAD 100S STERILIZER: CASSETTE LOT# UNK. (B)(6). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, SERVICE HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, FAILURE MODE AND EFFECTS ANALYSIS AND THE HEALTH HAZARD ANALYSIS. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED FOR BI LOT 092107 AND THERE WAS NO REPORT OF NON-CONFORMANCE FOUND THAT COULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THE COMPLAINT HISTORY FOR THE CYCLESURE BI DID NOT REVEAL A TREND FOR SUSPECTED POSITIVE BI. THE SERVICE HISTORY REVIEW OF THE STERRAD 100S STERILIZER WAS NOT PERFORMED TO ADDRESS A POSITIVE BI. THERE WAS NO REPORT OF STERILIZER MALFUNCTION. TRENDING ANALYSIS FOR SUSPECTED POSITIVE BI ISSUES ASSOCIATED TO THE CYCLESURE DID NOT INDICATE A SIGNIFICANT TREND. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED A LOW-SAFETY RISK. THE HHA (HEALTH HAZARD ANALYSIS) WAS REVIEWED AND THE ISSUE IS CONSIDERED TO BE NONE/NEGLIGIBLE RISK. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE TO THE REPORTED ISSUE IS NOT DETERMINED. THERE WERE NO PROBLEMS FOUND WITH THE RETAIN SAMPLE TESTING FROM THE REPORTED LOT. IT IS UNLIKELY THAT THE POSITIVE BI RESULT WAS ATTRIBUTED BY THE STERRAD 100S STERILIZER SINCE THERE WAS NO REPORT OF A STERILIZER MALFUNCTION. THE CYCLE COMPLETED AND THE CHEMICAL INDICATOR CHANGED COLOR FROM RED TO GOLD INDICATING SUFFICIENT EXPOSURE TO HYDROGEN PEROXIDE; THUS, THE UNKNOWN CASSETTE IS UNLIKELY TO BE THE CAUSE OF THE ISSUE. THE INCUBATION TEMPERATURE WAS SET TO THE REQUIRED SPECIFICATIONS; THEREFORE, THE THERMOMETER AND INCUBATOR AT THE CUSTOMER SITE UNLIKELY CONTRIBUTED TO THE POSITIVE BI RESULT. SINCE THE TRAY DATA WAS NOT PROVIDED, LOAD COMPATIBILITY COULD NOT BE CONFIRMED. THERE WAS NO SERVICE RECORD PERFORMED ADDRESSING A POSITIVE BI AT THE TIME OF THE EVENT. A SERVICE ORDER IS NOT REQUIRED IF THE CUSTOMER DID NOT EXPERIENCE TWO CONSECUTIVE POSITIVE BI EVENTS FROM THE SAME STERILIZER.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SUSPECT POSITIVE STERRAD CYCLESURE BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD 100S CYCLE. THE BI WAS FIRST READ AT 10 HOURS AND THEN CONFIRMED AFTER 24 HOURS. THE PROCESSED LOAD INCLUDED THREE STRYKER 1188 HD CAMERAS, TWO STRYKER 1088 HD CAMERAS AND ONE HARMONIC SCALPEL. THE LOAD CONTENTS WERE SUCCESSFULLY RECALLED WITH THE EXCEPTION OF TWO STRYKER 1188 HD CAMERAS. NO HARM OR INJURY HAS BEEN REPORTED DUE TO THIS EVENT. THE BI WAS PLACED AT THE BOTTOM SHELF IN THE BACK OF THE CHAMBER DURING PROCESSING. THE RESULTS OF THE PREVIOUS BI WAS NEGATIVE AND THE RESULTS OF THE SUBSEQUENT BI ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 092107

    Patients

    Seq Age Sex Outcome Treatment
    1