BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 3517617 · Received December 12, 2013

    Report

    Report Number
    2084725-2013-00549
    Event Type
    Injury
    Date Received
    December 12, 2013
    Date of Event
    May 19, 2011
    Report Date
    November 13, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD/BATCH RECORD REVIEW, PROBLEM CODE TRENDING AND SYSTEM HAZARD USE MISUSE ANALYSIS. THE DHR (DEVICE HISTORY RECORD)/BATCH RECORD REVIEW COULD NOT BE PERFORMED AS THERE WAS NO LOT NUMBER PROVIDED. (B)(4). THE SHUMA (SYSTEM HAZARD USE MISUSE ANALYSIS) HAS BEEN ASSESSED AS LOW AS REASONABLY PRACTICABLE. THE LOT NUMBER WAS NOT AVAILABLE FOR RETAIN EVALUATION. KARL STORZ CYSTOSCOPE LABELING CONTAINS THE WARNING NOT TO USE CIDEX OPA ON INSTRUMENTS USED ON BLADDER CANCER PATIENTS. THE LABELING OF CIDEX OPA SOLUTION INCLUDES CONTRAINDICATIONS FOR USE ON BLADDER CANCER PATIENTS. THE ASSIGNABLE CAUSE FOR THIS EVENT IS USER ERROR FOR NOT FOLLOWING THE IFU.

    Additional Manufacturer Narrative · 1

    RELATED MEDWATCH REPORTS: 2084725-2013-00547, 2084725-2013-00548 AND 2084725-2013-00549. THE CIDEX OPA SOLUTION IFU LISTS THE FOLLOWING CONTRAINDICATIONS: CIDEX OPA SOLUTION SHOULD NOT BE UTILIZED TO PROCESS ANY UROLOGICAL INSTRUMENTATION USED TO TREAT PATIENTS WITH A HISTORY OF BLADDER CANCER. IN RARE INSTANCES CIDEX OPA SOLUTION HAS BEEN ASSOCIATED WITH ANAPHYLAXIS-LIKE REACTIONS IN BLADDER CANCER PATIENTS UNDERGOING REPEATED CYSTOSCOPIES; CIDEX OPA SOLUTION SHOULD NOT BE UTILIZED TO PROCESS INSTRUMENTATION FOR PATIENTS WITH KNOWN SENSITIVITY TO CIDEX OPA SOLUTION OR ANY OF ITS COMPONENTS; CIDEX OPA SOLUTION SHOULD NOT BE USED TO STERILIZE HEAT SENSITIVE MEDICAL DEVICES. WHEN STERILIZATION BY A BIOLOGICALLY MONITORABLE PROCESS IS NOT FEASIBLE, HIGH LEVEL DISINFECTION OF RIGID ENDOSCOPES IS RECOMMENDED BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) AND THE ASSOCIATION FOR PROFESSIONALS IN INFECTION CONTROL AND EPIDEMIOLOGY (APIC).

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4), THE MANUFACTURER OF A CYSTOSCOPE MODEL 11272VNU. THE PATIENT REPORTED THAT HE HAD EXPERIENCED AN ALLERGIC REACTION AFTER THREE CYSTOSCOPIES (DATED (B)(6) 2010, (B)(6) 2011 AND (B)(6) 2011). ON THE FIRST TWO PROCEDURES, ALMOST IMMEDIATELY AFTER THE PROCEDURE, HE EXPERIENCED REDNESS OF HIS FACE AND SKIN BLOTCHES. ON THE THIRD PROCEDURE, HE REPORTED DIFFICULTY BREATHING ALONG WITH OTHER SYMPTOMS WHILE HE WAS STILL ON THE TABLE. HE WAS ADMITTED TO EMERGENCY ROOM ON ALL THREE OCCASIONS. HE WAS ADMINISTERED EPINEPHRINE TO ADDRESS ALLERGIC SYMPTOMS. HE WAS TREATED AND RELEASED. THE FACILITY CONFIRMED THEY USED CIDEX OPA SOLUTION FOR DISINFECTING THEIR CYSTOSCOPES. THE PATIENT AND FACILITY WERE PROVIDED THE MSDS FOR CIDEX OPA SOLUTION. ADDITIONALLY, THE SCOPE CLEANING INSTRUCTIONS STATE NOT TO USE CIDEX OPA SOLUTION ON INSTRUMENTS THAT ARE USED ON BLADDER CANCER PATIENTS DUE TO POSSIBLE ALLERGIC REACTIONS. THE FACILITY REPORTED THAT THE DOCTOR WHO PERFORMED THE PROCEDURES WAS NO LONGER AFFILIATED WITH THEIR CENTER AND THEY WERE NOT PERFORMING THIS PROCEDURE. THIS REPORT IS FOR EVENT 3 OF 3 ((B)(6) 2011). REFERENCE: MEDWATCH 9610617-2011-00035 DATED 8/19/2011, REPORTED BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650166 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EPINEPHRINE