BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1882184 · Received October 25, 2010

    Report

    Report Number
    2150060-2010-00076
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K832458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: OLYMPUS SCOPE - MODEL NUMBER 180.CIDEX® OPA SOLUTION - PRODUCT CODE: 20390, LOT NUMBER UNKNOWN.(B)(4) - NO CODE AVAILABLE: ISCHEMIC COLITIS.AN ASP FSE ASSESSED THE UNIT ONSITE. HE ADJUSTED THE AIR PRESSURE FROM 15PSI TO 20PSI. HE TESTED THE UNIT AND IT IS WORKING FINE. THE UNIT MEETS MANUFACTURER'S SPECIFICATIONS.THIS IS ONE OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS:2150060-2010-0076 AND 2150060-2010-0078.

    Additional Manufacturer Narrative · 1

    EVENT TYPE: INITIAL REPORT WAS REPORTED INCORRECTLY AS PRODUCT PROBLEM; IT IS CORRECTED TO ADVERSE EVENT. CORRECTION: DEVICE MANUFACTURE DATE: 12/2002. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A DEVICE HISTORY RECORD REVIEW, A REVIEW OF THE COMPLAINT HISTORY TRENDING, SERVICE HISTORY TRENDING, DEVICE HISTORY RECORD REVIEW, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE AND MISUSE ANALYSIS, HEALTH HAZARD EVALUATION AND CAPA. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED FOR THE AER UNIT WHICH MET ALL MANUFACTURER'S SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE HISTORY TRENDING WAS REVIEWED FOR THE AER UNIT. THERE IS NO TREND FOR HUMAN REACTION ISSUES. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) WAS REVIEWED FOR THE AER. THE RISK PRIORITY NUMBERS FOR FAILURE MODES IS BELOW 100 AND IS CONSIDERED LOW RISK. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) WAS REVIEWED FOR THE CIDEX OPA WHICH REVEALED THE RISK PRIORITY NUMBER (RPN) FOR CHEMICAL COLITIS TO BE ABOVE THE THRESHOLD OF 100. THE RECOMMENDED ON-GOING VIGILENCE AND MONITORING HAS BEEN UNDER TAKEN BY AN ASP SALES REPRESENTATIVE AND ACCOUNT MANAGER. THE SHUMA (SYSTEM HAZARD USE AND MISUSE ANALYSIS) FOR CIDEX OPA SOLUTION/DISOPA WAS REVIEWED AND IT WAS DETERMINED THAT THE RISKS ASSOCIATED WITH CIDEX OPA EXPOSURE ARE ALL CATEGORY I AND IS MODERATE RISK. THE HHE WAS COMPLETED AND THE RISK ASSOCIATED WITH SUCH FAILURES WAS FOUND TO BE LOW. AN ASP SALES REPRESENTATIVE AND AN ACCOUNT MANAGER VISITED THE SITE TO CHECK THE SCOPE CONNECTION PRACTICES OF THE CUSTOMER AND TO PERFORM AN AER IN-SERVICE IN OCTOBER 2010. ADDITIONALLY, THE CUSTOMER WAS PROVIDED WITH 180 OLYMPUS SCOPE DIAGRAMS TO USE AS A REFERENCE GUIDE DURING SCOPE CONNECTION PROCESS. THE ROOT CAUSE FOR THIS ISSUE IS KNOWN TO BE IMPROPER SCOPE CONNECTION PRACTICES AND IS ADDRESSED IN A CAPA. THE ISSUE OF IMPROPER SCOPE CONNECTION PRACTICE WAS FOUND TO RESULT IN RESIDUAL FLUID IN THE SCOPES. PRESENCE OF RESIDUAL FLUID DUE TO IMPROPER SCOPE CONNECTION PRACTICES BY AN AER OPERATOR MAY CAUSE CHEMICAL COLITIS IN A PATIENT DURING A COLON EXAM. THERE IS NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A WET OLYMPUS (180) SCOPE WAS USED ON A PATIENT AFTER A COMPLETED CYCLE IN THEIR ASP AUTOMATIC ENDOSCOPIC REPROCESSOR (AER). THE PATIENT EXPERIENCED ISCHEMIC COLITIS THAT THE USER HAS ALLEGED WAS DUE TO THE WET SCOPE (SUSPECTED RESIDUAL FLUID) THAT WAS USED DURING A COLONOSCOPY PROCEDURE. THE PATIENT HAD A SECOND COLONOSCOPY TO CONFIRM THE DIAGNOSIS AND TO DETERMINE THE APPROPRIATE TREATMENT FOR THE DIAGNOSIS. THE PATIENT WAS TREATED AND IS DOING FINE NOW. AN ASP FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT. THIS IS COMPLAINT ONE OF TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER AER EQUIPMENT KOG MINNTECH CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR