BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISOPA SOLUTION

    MDR report key: 1904685 · Received November 22, 2010

    Report

    Report Number
    2084725-2010-00303
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: PANASONIC BIOPLORER - PART AND SERIAL NUMBER UNKNOWN. ENDOCLENS (AER) - PART AND SERIAL NUMBER UNKNOWN.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, BATCH RECORD REVIEW, SYSTEM HAZARD USE MISUSE ANALYSIS AND FAILURE MODE EFFECT ANALYSIS. COMPLAINT HISTORY TRENDING FOR DISOPA SOLUTION FOR THE PROBLEM OF "STERILITY CLAIM(S)" DID NOT REVEAL ANY SIGNIFICANT TREND. BATCH RECORD REVIEW OF DISOPA WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNKNOWN. THE SHUMA (SYSTEM HAZARD USE MISUSE ANALYSIS) HAS BEEN ASSESSED A CATEGORY I - BROADLY ACCEPTABLE RISK. THE FMEA FOR CIDEX OPA WAS REVIEWED. THE FMEA SCORE FOR INEFFECTIVE PRODUCT DUE TO MANUFACTURING ERROR AND RISK OF INFECTION IS BELOW THE THRESHOLD OF 100. DURING FURTHER FOLLOW-UP BY ASP, THE AFFILIATE INDICATED THE RETURNED SAMPLE WAS STERILE WATER PASSED THROUGH THE SCOPE CHANNEL, NOT THE ACTUAL DISOPA SOLUTION. THERE WAS NO INFORMATION AVAILABLE REGARDING THE ORGANISM FOUND, OR THE CONCOMITANT PRODUCTS IN THIS COMPLAINT (ENDOSCOPE, ENDOCLENS, AND PANASONIC BIOPLORER. THE AFFILIATE STATED NO FURTHER INFORMATION IS AVAILABLE FOR THIS COMPLAINT. THE DISOPA SPECIFIC SOLUTION LOT NUMBER WAS NOT REPORTED. DISOPA SOLUTION IS MANUFACTURED IN (B)(4) AND SOLD EXCLUSIVELY IN (B)(4). DISOPA IS SIMILAR TO CIDEX OPA SOLUTION SOLD IN THE UNITED STATES.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED THAT VIABLE BACTERIUM WAS FOUND IN A UPPER GASTROINTESTINAL ENDOSCOPE AFTER PROCESSING WITH DISOPA SOLUTION IN THE ENDOCLENS AUTOMATIC ENDOSCOPIC REPROCESSOR (AER). THE ENDOSCOPE WAS TESTED FOR BACTERIA USING A PANASONIC BIOPLORER (BACTERIOLOGICAL TESTING APPARATUS). THE CUSTOMER HAD BEEN USING THE ENDOSCOPE FOR ABOUT TEN YEARS. THERE HAVE BEEN NO HUMAN INJURIES REPORTED DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION BIOCIDES SOLUTIONS MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1