BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA BRONCHOVIDEOSCOPE

    MDR report key: 5467233 · Received February 29, 2016

    Report

    Report Number
    2951238-2016-00106
    Event Type
    Injury
    Date Received
    February 29, 2016
    Report Date
    February 29, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K112846
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS PERFORMED A PHYSICAL INSPECTION OF THE BRONCHOSCOPE ON-SITE AT THE HOSPITAL. THE HOSPITAL INFORMED OLYMPUS THAT THE BIOPSY CHANNEL ON THE BRONCHOSCOPE HAD BEEN REPLACED BY A THIRD PARTY, NON-OLYMPUS REPAIR COMPANY ON (B)(4) 2007. IN ORDER TO REPLACE THE BIOPSY CHANNEL, THE THIRD PARTY NEEDED TO PARTIALLY DISASSEMBLE THE DEVICE TO REMOVE THE BIOPSY PORT AND/OR REPLACE OTHER PARTS. AT THE HOSPITAL'S REQUESTS, OLYMPUS CONDUCTED A VERY LIMITED PHYSICAL INSPECTION OF THE BRONCHOSCOPE. THE BIOPSY PORT ASSEMBLY WAS FOUND LOOSE. NON-OLYMPUS REPAIR AND PARTS WERE USED, INCLUDING THE BENDING SECTION AND INSERTION TUBE. DENTS WERE FOUND ON THE INSERTION TUBE, WHICH CAN RESTRICT THE PASSAGE OF CLEANING BRUSHES. OLYMPUS REQUESTED THAT THE SCOPE BE RETURNED TO OLYMPUS FOR A MORE IN-DEPTH INSPECTION; HOWEVER, THE HOSPITAL HAS NOT AGREED AT THIS TIME. AS PART OF THIS INVESTIGATION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE FACILITY TO PROVIDE AN IN-SERVICE AND NOTED THE FOLLOWING OBSERVATIONS: NO PRE-CLEANING AT BEDSIDE, EXTENDED DELAYS IN REPROCESSING ENDOSCOPES AFTER USE, LEAK TESTING WAS PERFORMED IN THE DETERGENT SOLUTION AS OPPOSED TO USING CLEAN WATER, ENZOL DETERGENT USED FOR MANUAL CLEANING WAS BEING REUSED, NO SUCTION WAS BEING USED TO ASPIRATE THE DETERGENT THROUGH THE INSTRUMENT AND SUCTION CHANNELS DURING MANUAL CLEANING. IT WAS ALSO NOTED THAT THE BRONCHOSCOPE WAS NOT BEING IMMERSED IN CLEAN WATER AND THE CHANNELS WERE NOT BEING FLUSHED WITH CLEAN WATER TO RINSE THE DETERGENT PRIOR TO LOADING IN THE AUTOMATED ENDOSCOPE REPROCESSOR (AER). IT WAS ALSO NOTED THAT THE ENZOL DETERGENT WAS NOT BEING DILUTED PROPERLY IN THE MEDIVATOR'S AER. THE CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, THE USE OF NON-OLYMPUS REPAIR AND PARTS CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    OCA UNDERTOOK A RETROSPECTIVE REVIEW OF ITS MDR FILES FOR THE PERIOD OF JANUARY 2005 TO APRIL 2015. BASED UPON THIS REVIEW, WE ARE SUBMITTING THIS MDR TO SEPARATELY ACCOUNT FOR EACH OF THE THIRTEEN PATIENTS INVOLVED IN THIS EVENT. THE HOSPITAL REPORTED THAT POSITIVE CULTURE RESULTS WERE OBTAINED FROM THE BRONCHOSCOPE AND THAT THE HOSPITAL HAD THIRTEEN PATIENTS THAT MAY HAVE EXPERIENCED POSSIBLE BACTERIAL LUNG INFECTION WITH PSEUDOMONAS PUTIDA AND PSEUDOMONAS AERUGINOSA. THE HOSPITAL ALSO INDICATED THAT SOME PATIENTS HAVE TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIAS. THE HOSPITAL REPORTED THAT THE BIOPSY PORT ON THE BRONCHOSCOPE WAS LOOSE AND COULD BE TWISTED OFF THE BRONCHOSCOPE BY MEDICAL STAFF. THE HOSPITAL IS INVESTIGATING THE ROLE OF THE BRONCHOSCOPE IN THIS EVENT. THE HOSPITAL HAS REPORTED THE PATIENTS WERE ADMINISTERED PROPHYLACTIC ANTIBIOTICS. THE HOSPITAL HAS NOTIFIED THE POTENTIALLY INFECTED PATIENTS BY LETTER FOR SURVEILLANCE AND FOLLOW-UP TESTING. IN ADDITION, THE FACILITY REPORTED TWO OLYMPUS BRONCHOSCOPES (MODEL # BF-160) THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT INFECTIONS; HOWEVER, IT IS UNKNOWN WHICH DEVICE WAS USED TO EXAMINE THE THIRTEEN PATIENTS. THE SERIAL NUMBERS OF THE BRONCHOSCOPES ARE (B)(4). PLEASE CROSS REFERENCE MFR. REPORT NUMBERS: 8010047-2008-00088, 8010047-2008-00089, 2951238-2016-00099, 2951238-2016-00100, 2951238-2016-00101, 2951238-2016-00102, 2951238-2016-00103, 2951238-2016-00104, 2951238-2016-00105, 2951238-2016-00107, 2951238-2016-00108, AND 2951238-2016-00109 TO ACCOUNT FOR THE THIRTEEN PATIENTS AS REFERENCED IN THE ORIGINAL REPORT. THE INITIAL TWO REPORTS WILL BE SUPPLEMENTED TO CROSS REFERENCE THE THIRTEEN ASSOCIATED INFECTION COMPLAINTS: 8010047-2008-00088 AND 8010047-2008-00089.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122422 EVIS EXERA BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORPORATION BF-160 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R