BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5498994 · Received March 14, 2016

    Report

    Report Number
    9610877-2016-00074
    Event Type
    Injury
    Date Received
    March 14, 2016
    Report Date
    January 22, 2015
    Manufacturer
    PENTAX
    Product Code
    EOQ
    PMA / PMN Number
    REFER TO H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE MODEL IS AN IFE (IMPORT FOR EXPORT) THEREFORE 510(K) DOES NOT APPLY. HOYA CORPORATION (B)(4), SPECIFICATION DEVELOPER, (B)(4). PENTAX OF AMERICA, INC., (B)(4). PENTAX OF AMERICA, INC. ((B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX (B)(4) OFFICE ((B)(4)). THIS MDR WAS INITIATED AS PART OF A CAPA-DRIVEN REMEDIATION EFFORT RELATED TO FILING OF MDRS FOR COMPLAINTS/EVENTS OUTSIDE OF THE US (OUS). AS PART OF THIS REMEDIATION, PENTAX MEDICAL PERFORMED A RETROSPECTIVE MDR ASSESSMENT OF ALL OUS EVENTS/COMPLAINTS RECEIVED SINCE JAN 2013. THE RETROSPECTIVE ASSESSMENT OF THIS EVENT PROMPTED PENTAX MEDICAL TO FILE THIS REPORT. (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN PENTAX (B)(4) STATING "DURING EXAMINATION, THE PATIENT BEGAN TO BLEED IN AUTO FLUORESCENT MODE. THE IMAGE WAS ALL BLACK, MAKING EXAMINATION IMPOSSIBLE AND DANGEROUS" PENTAX MODEL EB-1570AK/SERIAL (B)(4). THIS EVENT WAS REPORTED TO (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER E2015036.

    Description of Event or Problem · 1

    BASED ON THE FINAL REPORT SUBMITTED TO (B)(6) BY PENTAX EUROPE, "DURING A BRONCHOSCOPY, IT AN INCREASING LOSS OF LIGHT WAS OBSERVED. FOLLOWING A GESTURE, A SLIGHT BLEEDING OCCURRED ENDING TO ABSORB THE REST OF LIGHT. EXPLORATION WAS THEREFORE IMPOSSIBLE WITH AUTO FLUORESCENCE. THE FURTHER INVESTIGATION WAS CONDUCTED WITHOUT THIS TECHNIQUE. THE LOSS OF LIGHT WHEN USING WITH AUTO FLUORESCENCE BRONCHOSCOPES CONTINUES TO EXIST." THE FINAL REPORT TO (B)(6) ALSO STATED NO CLINICAL CONSEQUENCES OBSERVED NOR NEGATIVE IMPACT ON PATIENTS HEALTH CAME TO OUR KNOWLEDGE. THE REMEDIAL ACTION TAKEN BY THE FACILITY, AS STATED IN THE FINAL REPORT TO (B)(6), WAS TO USE ANOTHER BRONCHOSCOPE WITH AUTO FLUORESCENCE TO VERIFY IF AN IMPROVEMENT WAS OBSERVED WHEN UNDER AUTO FLUORESCENCE BRONCHOSCOPY. NO IMPROVEMENT WAS OBSERVED, THEREFORE, THE VIDEO PROCESSOR AND THE TWO BRONCHOSCOPES WITH AUTO FLUORESCENCE WERE QUARANTINED AT THE BIOMEDICAL WORKSHOP. BASED ON THE FINAL REPORT TO (B)(6), THE MANUFACTURER'S DEVICE ANALYSIS RESULTS WERE STATED AS "THE INVESTIGATION AT OUR WORKSHOP REVEALED DEVICE EB-1570AK, SERIAL NO.: (B)(4) IS SUFFERING FROM A LEAKAGE WHICH MUST HAVE BEEN DETECTED BY THE USER DURING THE REGULAR REPROCESSING PROCEDURES AND ROUTINE CHECKS PRIOR TO EACH USE. THIS LEAKAGE RESULTED IN WATER INGRESSION WHICH HAS LED TO SIGNIFICANT DAMAGES. AMONGST OTHER DEFECTS THE LIGHT EMISSION IS REDUCED BY 90%, SO THE REMAINING LIGHT EMISSION WAS 10%. MINIMUM LIGHT EMISSION THAT IS REQUIRED TO USE THE AUTOFLUORESCENCE TECHNIQUE IS 80%. FURTHERMORE, THE POOR CONDITION OF THE DEVICE MUST HAVE DEVELOPED SINCE LONGER TIME AS THERE IS SIGNIFICANT CORROSION TO BE SEEN. THIS DEVICE WAS INVOLVED IN THE INITIAL PROCEDURE. REGARDING THE DEVICE EB-1570AK SER. NO.: (B)(4): SCOPE WITH SMALL LEAKAGE IN SIDE COVER AREA. MINOR REPAIR REQUIRED. NO SPECIAL CIRCUMSTANCES DETECTABLE. NORMAL FUNCTION. NO WATER DAMAGE. REGARDING THE VIDEO PROCESSOR SAFE3000 SER. NO.: (B)(4): OPTICAL ASSESSEMENT: GOOD CONDITION IN GENERAL. NO SPECIAL TREATMENTS DETECTABLE. DAMAGE: LAMP GLASS BROKEN, DUST, FOG INSIDE TOP GLASS OF LAMP. TEST OF FUNCTIONALITY: NOISE FROM VENTILATION WHEN SWITCHING ON THE DEVICE (VENTILATION GRID BROKEN). PROCESSOR TRIES TO START THE XENON LAMP FOR SEVERAL TIMES. NO IGNITION POSSIBLE. A WARNING APPEARS ON THE MONITOR "XE LAMP WARNING", RED LAMP "AUX" ON PROCESSOR TURNS ON WHICH MEANS: THE AUXILIARY LAMP WAS ENABLED, THE DEVICE IS WORKING IN "SAFETY MODE". THIS IS SUPPORTING THE CONTROLLED WITHDRAWAL OF THE SCOPE OUT OF THE PATIENT ONLY. THERE IS NO EXAMINATION POSSIBLE. NO FURTHER FUNCTIONALITY (INCL. STARTING AUTOFLUORESCENCE MODE/ LASER, EXCL. PUMP) IS AVAILABLE UNDER THESE CONDITIONS." AS FURTHER STATED IN THE FINAL REPORT TO (B)(6), "ROOT CAUSE OF THIS INCIDENT IS IMPROPER (USER-) MAINTENANCE OF THE ENDOSCOPIC EQUIPMENT, ESPECIALLY OF THE VIDEO PROCESSOR, WHICH WAS TECHNICALLY NOT READY TO BE USED. ALL SAFETY FUNCTIONS AND ALERTS ADDRESSING THE POOR CONDITION WORKED PROPERLY. WARNINGS / ALERTS GIVEN BY THE INSTRUMENT HAVE BEEN IGNORED BY THE USER. PENTAX EUROPE IS CLASSIFYING THIS AS A USER ERROR. THERE WAS NO MALFUNCTION RELATED TO OUR DEVICES. PENTAX EUROPE (B)(4) WILL NOT TAKE ANY FURTHER ACTION REGARDING THIS CASE." ON 20/JUL/2016, A DEVICE HISTORY REVIEW WAS PERFORMED WHICH CONFIRMED THE BRONCHOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. IN ADDITION, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. SINCE NO FURTHER INFORMATION, HAS BEEN RECEIVED FOR THIS EVENT, PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153588 PENTAX VIDEO BRONCHOSCOPE - AUTOFLOURECENT EOQ PENTAX EB-1570AK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other