BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5171789 · Received October 23, 2015

    Report

    Report Number
    9610877-2015-00021
    Event Type
    Injury
    Date Received
    October 23, 2015
    Date of Event
    January 1, 2015
    Report Date
    September 24, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    PMA / PMN Number
    K131028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA CORPORATION PENTAX (B)(4). PENTAX OF AMERICA, INC (B)(4) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MDR 9610877-2015-00013 INCLUDES INFORMATION RECEIVED FOR PATIENT 1, MDR 9610877-2015-00014 INCLUDES INFORMATION RECEIVED FOR PATIENT 2, MDR 9610877-2015-00015 INCLUDES INFORMATION RECEIVED FOR PATIENT 3, MDR 9610877-2015-00016 INCLUDES INFORMATION RECEIVED FOR PATIENT 4, MDR 9610877-2015-00017 INCLUDES INFORMATION RECEIVED FOR PATIENT 5, MDR 9610877-2015-00018 INCLUDES INFORMATION RECEIVED FOR PATIENT 6, MDR 9610877-2015-00019 INCLUDES INFORMATION RECEIVED FOR PATIENT 7, MDR 9610877-2015-00020 INCLUDES INFORMATION RECEIVED FOR PATIENT 8, MDR 9610877-2015-00021 INCLUDES INFORMATION RECEIVED FOR PATIENT 9.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL MDR 9610877-2015-00013 INCLUDES INFORMATION RECEIVED FOR PATIENT 1, INITIAL MDR 9610877-2015-00014 INCLUDES INFORMATION RECEIVED FOR PATIENT 2, INITIAL MDR 9610877-2015-00015 INCLUDES INFORMATION RECEIVED FOR PATIENT 3, INITIAL MDR 9610877-2015-00016 INCLUDES INFORMATION RECEIVED FOR PATIENT 4, INITIAL MDR 9610877-2015-00017 INCLUDES INFORMATION RECEIVED FOR PATIENT 5, INITIAL MDR 9610877-2015-00018 INCLUDES INFORMATION RECEIVED FOR PATIENT 6, INITIAL MDR 9610877-2015-00019 INCLUDES INFORMATION RECEIVED FOR PATIENT 7, INITIAL MDR 9610877-2015-00020 INCLUDES INFORMATION RECEIVED FOR PATIENT 8, INITIAL MDR 9610877-2015-00021 INCLUDES INFORMATION RECEIVED FOR PATIENT 9.

    Description of Event or Problem · 1

    PENTAX EUROPE (B)(4) COULD NOT IDENTIFY THE ROOT CAUSE OF THIS EVENT. A DEVICE HISTORY REVIEW WAS PERFORMED ON 12/21/2015 CONFIRMING THE VIDEO BRONCHOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. PENTAX MEDICAL CLOSED THIS COMPLAINT ON 11/21/2016 AND SINCE NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, PENTAX EUROPE (B)(4) SUBMITTED A FINAL REPORT TO (B)(4) WHICH STATED THE 9 PATIENTS PREVIOUSLY MENTIONED IN THIS REPORT UNDERWENT A PULMONARY BRONCHOSCOPY WITH A BRONCHO-ALVEOLAR LAVAGE BETWEEN (B)(6) 2015. THIRD PARTY SINGLE-USE BOSTON SCIENTIFIC FORCEPS WERE USED DURING THE PROCEDURE. ACCORDING TO INFORMATION PROVIDED BY THE USER, THE WASHER DISINFECTOR DID NOT REVEAL ANY DEVIATIONS DURING REPROCESSING OF THE DEVICE DURING THIS PERIOD. THE FINAL REPORT ALSO STATED THE HEALTH CONDITION OF THE PATIENT IDENTIFIED IN THIS MDR WAS NOT REPORTED TO PENTAX EUROPE (B)(4). ON 11/28/2015, THE DEVICE WAS RECEIVED BY PENTAX EUROPE (B)(4) FROM PENTAX (B)(6). INSPECTION WAS PERFORMED AND THE DEVICE WAS FOUND IN GOOD CONDITION (I.E. FULLY OPERATIONAL). IN ORDER TO ASSESS THE ROOT CAUSE OF THE BACTERIAL CONTAMINATION, THE DEVICE WAS REPROCESSED IN AN AUTOMATED WASHER DISINFECTOR (GLUTARALDEHYDE-BASED). IMMEDIATELY AFTER REPROCESSING, THE DEVICE WAS SEALED AND SENT TO A LABORATORY IN ORDER TO ASSESS THE EFFICACY OF THE MECHANICAL REPROCESSING, ESPECIALLY OF THE BIOPSY AND THE SUCTION CHANNELS. THE MICROBIOLOGICAL INVESTIGATION AT THE LABORATORY, CONCLUDED ON (B)(6) 2015, CONFIRMED NO DETECTION OF BACTERIA (SERRATIA MARCESCENS (WILD RED)). THE DEVICE INVOLVED IN THIS EVENT WAS SENT BACK TO PENTAX (B)(6) ON 12/09/2015 AFTER A MINOR REPAIR WAS PERFORMED (REPLACEMENT OF THE REMOTE CONTROL BUTTON). (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT STATING "9 CASES OF RESPIRATORY SPECIMENS TESTED POSITIVE FOR SERRIATA MARCESCENS (NMR-NUCLEAR MAGNETIC RESONANCE) RED WILD S.MARCESCENS. SEVEN PATIENTS WERE HOSPITALIZED AND TWO PATIENTS WERE OUTPATIENTS. EACH PATIENT HAD A PULMONARY FIBROSCOPY WITH BRONCHO-ALVEOLAR LAVAGE USING VIDEO BRONCHOSCOPE EB-1575K/SERIAL (B)(4). THE VIDEO BRONCHOSCOPE WAS SEQUESTERED AFTER A BIOLOGICAL SAMPLE FROM THE VIDEO BRONCHOSCOPE TESTED POSITIVE FOR SERRIATA MARCESCENS (NMR-NUCLEAR MAGNETIC RESONANCE) RED WILD S.MARCESCENS ON (B)(6) 2015. THE PREVIOUS BACTERIOLOGICAL SAMPLING WAS MADE ON (B)(6) 2015 WITH ACCEPTABLE RESULTS. THE REPORT ALSO STATED THE VIDEO BRONCHOSCOPE IS REPROCESSED IN THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) ITERATIVELY. THE AER IS ALSO BIOLOGICALLY MONITORED AND HAS TESTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700927 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB-1575K

    Patients

    Seq Age Sex Outcome Treatment
    1