BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 2871133 · Received December 12, 2012

    Report

    Report Number
    2084725-2012-00126
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED TRENDING FOR PROBLEM CODE: (B)(4) THUS NO TREND WAS OBSERVED. (B)(4).

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE MISUSE ANALYSIS AND HEALTH HAZARD EVALUATION. COMPLAINT HISTORY TRENDING FOUND 2 COMPLAINTS IN THE PAST 12 MONTHS ((B)(6) 2012 TO (B)(6) 2013), WHICH ARE BOTH RELATED TO THIS ONE EVENT. THUS NO SIGNIFICANT TREND WAS OBSERVED. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) SCORE FOR USER SIMILAR USER SYMPTOMS IS BELOW THE THRESHOLD OF 100. THE SHUMA (SYSTEM HAZARD USE MISUSE ANALYSIS) HAS BEEN ASSESSED AS LOW AS REASONABLY PRACTICABLE. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR SIMILIAR ISSUES INDICATED THAT THE HAZARD/RISK IS LOW. THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION. THE PRODUCT IFU CARRIES WARNINGS AND GENERAL DIRECTIONS ABOUT RINSING DEVICES AFTER DISINFECTION. REMOVING EXCESS PRODUCT IS IMPORTANT AS EXPOSURE IS KNOWN TO CAUSE STAINING AND IRRITATION TO THE SKIN AND/OR MUCOUS MEMBRANES. THERE WAS NO RESPONSE FROM THE CUSTOMER FOR FOLLOW UP INFORMATION. DUE TO INSUFFICIENT INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A FACILITY REPORTED A PATIENT HAD SYMPTOMS OF BLOODY, MUCOUS DIARRHEA AFTER A COLONOSCOPY WAS PERFORMED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER 24 HOURS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. FOLLOW UP WITH THE FACILITY ON (B)(6) 2012 CONFIRMED THAT THE PATIENT IS DOING FINE. THE FACILITY IS ALLEGING THAT RESIDUAL DISINFECTANT LEFT IN SCOPES AFTER PROCESSING CAUSED THE INJURY. IT IS NOTED THAT THERE HAVE BEEN INCIDENTS WHEN THEY SEE "GRAYISH FLUID" DRIPPING FROM SCOPES AFTER PROCESSING IN THE AER. THE SCOPES ARE PRE-CLEANED WITH EMPOWER ENZYMATIC SOLUTION, USING THE RECOMMENDED AMOUNT. THE OLYMPUS SCOPES ARE BRUSHED THOROUGHLY WHEN USING DETERGENT AND THEN RINSED 2-3 TIMES AFTER BRUSHING. THE FACILITY USES CIDEX-OPA FOR DISINFECTION IN THE ASP AUTOMATIC ENDOSCOPIC PREPROCESSOR. (B)(4). THIS IS ONE OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2012-00126 AND 2084725-2012- 00127.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization