BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA DUODENOSCOPE

    MDR report key: 5107271 · Received September 28, 2015

    Report

    Report Number
    8010047-2015-00841
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    July 17, 2008
    Report Date
    May 8, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS NOT RETURNED TO OMSC BUT TO OLYMPUS (B)(4). THE EVALUATION CONFIRMED THAT THERE WAS VISIBLE DEBRIS AROUND FORCEPS ELEVATOR AND BIOFILMS ON THE INNER SURFACE OF THE CHANNELS WITHOUT CHANNEL DAMAGE. THE DEBRIS LIKELY COULD HAVE BEEN REMOVED BY PROPER MANUAL CLEANING. THE SUBJECT SCOPE WAS RETURNED TO THE FACILITY AFTER REPLACING THE CHANNELS. OBV STAFF VISITED THE FACILITY TO INVESTIGATE THE REPROCESSING STEP AND FOUND THE FACILITY DID NOT CONNECT ALL CHANNELS TO THE DRYING CABINET. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE 8010047-2015-00840, 8010047-2015-00842, 8010047-2015-00856.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BECAME AWARE OF A MEDICAL JOURNAL ARTICLE; ENDOSCOPY 2009 REPORTING THREE PATIENTS INFECTIONS OF MULTIDRUG-RESISTANT PSEUDOMONAS AERUGINOSA AFTER HAVING UNDERGONE ENDOSCOPE RETROGRADE CHOLANGIO PANCREATOGRAPHY(ERCP) AND THE DETECTION OF THE P. AERUGINOSA IN ROUTINE CULTURING OF ENDOSCOPE. OMSC INVESTIGATED IF THE EVENT WAS ASSOCIATED WITH OMSC PRODUCT, AND CONFIRMED THAT A TJF-145 WAS INCLUDED IN THE EVENT ON (B)(6), 2015. IN THE MEDICAL ARTICLE, IT WAS REPORTED AS FOLLOWING; FIRST PATIENT DEVELOPED HIGH FEVER SIX DAYS AFTER AN ERCP ON (B)(6), 2008 AND A MULTIDRUG-RESISTANT P. AERUGINOSA, SENSITIVE TO TOBRAMYCIN AND POLYMYXINS AND RESISTANT TO BETA-LACTAM ANTIBIOTICS. FLUOROQUINOLONES WAS ISOLATED FROM SEVERAL SETS OF BLOOD CULTURES AND FROM A RECTAL SWAB. THE FIRST PATIENT WAS TREATED WITH INTRAVENOUS ANTIMICROBIAL COMBINATION THERAPY AND WAS DISCHARGED FROM THE HOSPITAL. SECOND PATIENT COMPLAINED CHILLS AND SWEARS AND DEVELOPED HIGH FEVER 6 WEEKS AFTER AN ERCP ON (B)(6), 2008. MULTI DRUG P. AERUGINOSA WAS ISOLATED FROM HER BLOOD CULTURES AND THE SECOND PATIENT WAS TREATED WITH MEDICINE. IN (B)(6) 2008, A THIRD PATIENT WAS FOUND TO DEVELOP SEPSIS, WITH A SIMILAR STRAIN OF P. AERUGINOSA, WHO HAD UNDERGONE ERCP (IN SEPTEMBER) WITH THE SAME ENDOSCOPE. THE SCOPE WAS REMOVED FROM SERVICE IN OCTOBER 2008 DUE TO THREE TIMES ISOLATION OF THE P. AERUGINOSA FROM THE CHANNEL IN ROUTINE CULTURE. FOLLOWING GAS STERILIZATION IN (B)(6) 2008, THE IMPLICATED ENDOSCOPE WAS FOUND TO HAVE P. AERUGINOSA-NEGATIVE CULTURES AND WAS RE-INTRODUCED INTO SERVICE. HOWEVER, 4 MONTHS LATER, IT WAS FOUND TO BE AGAIN CONTAMINATED WITH P. AERUGINOSA. THE ENDOSCOPE WAS SENT TO THE MANUFACTURER FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638989 EVIS EXERA DUODENOSCOPE DOUDENOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION TJF-145 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other