BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 6238420 · Received January 10, 2017

    Report

    Report Number
    9610877-2016-00025
    Event Type
    Injury
    Date Received
    January 10, 2017
    Report Date
    November 16, 2009
    Manufacturer
    PENTAX
    Product Code
    EOQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (EXEMPTION NUMBER E2015036). (B)(4). THIS MDR WAS INITIATED AS PART OF A RETROSPECTIVE ASSESSMENT OF COMPLAINTS/EVENTS IN THE US. AS PART OF THIS ASSESSMENT, PENTAX MEDICAL EVALUATED ALL US EVENTS/COMPLAINTS RECEIVED FOR CURRENTLY MARKETED BRONCHOSCOPES. THE RESULTS OF THIS RETROSPECTIVE ASSESSMENT PROMPTED PENTAX MEDICAL TO FILE THIS REPORT. OTHER RELEVANT DEVICES (COMMON DEVICE NAME/ PRODUCT CODE/ MODEL/ PMA-510(K)). VIDEO BRONCHOSCOPE/ EOQ/ EB-1170K/ K131028. VIDEO BRONCHOSCOPE/ EOQ/ EB-1570/ K023376. AUTOFLUORESCENCE VIDEO BRONCHOSCOPE/ EOQ/ EB-1570AK/ IFE-IMPORT FOR EXPORT. VIDEO BRONCHOSCOPE/ EOQ/ EB-1570K/ K131028. AUTOFLUORESCENCE VIDEO BRRONCHOSCOPE/ EOQ/ EB-1970AK/ IFE-IMPORT FOR EXPORT. VIDEO BRONCHOSCOPE/ EOQ/ EB-1970K/ K131028. VIDEO BRONCHOSCOPE/ EOQ/ EB-1970TK/ K131028. ULTRASOUND VIDEO BRONCHOSCOPE/ EOQ/EB-1970UBK-NOT SOLD IN US. ULTRASOUND VIDEO BRONCHOSCOPE/ EOQ/ EB-1970UK/ K131946. VIDEO BRONCHOSCOPE/ EOQ/ EB-P1170K/ K023376. VIDEO CYSTOSCOPE/ FAJ/ ECY-1570/ K914008. VIDEO CYSTOSCOPE/ FAJ/ ECY-1570K/ K914008. VIDEO CYSTOSCOPE/ FAJ/ ECY-1571K-NOT SOLD IN US. VIDEO NASO PHARYNGO LARYNGOSCOPE/ EOB/ VNL-1570K/ K921707(NONE SOLD IN US). VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE/ EQL/ VNL-1570STK/ IFE. THE VNL-1570STK WAS HISTORICALLY DESIGNATED AS A LARYGOSTROBOSCOPE (CLASS I EXEMPT). HOWEVER, DUE TO THE PRESENCE OF AN INSTRUMENT CHANNEL, THIS SCOPE IS MORE ACCURATELY CHARACTERIZED AS A NASOPHARYNGOLARNGOSCOPE (CLASS II REQUIRING 510(K). AFTER DISCUSSION WITH FDA, A 510(K) WAS SUBMITTED AND IS CURRENTLY UNDER REVIEW. AS A RESULT, THIS ENDOSCOPE IS CURRENTLY ON IFE STATUS-IMPORT FOR EXPORT AND ONLY BEING IMPORTED FROM JAPAN FOR EXPORT TO LATIN AMERICA AND CANADA IF REGISTERED FOR SALE IN THOSE REGIONS. VARIABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2009, PENTAX MEDICAL WAS MADE AWARE OF A FACILITY REPORT OF CULTURES OF A VIRUS (UNSPECIFIED) FOUND OVER A 4 TO 6 WEEK PERIOD IN NINE (9) PATIENTS AFTER THEY HAD BEEN EXAMINED WITH PENTAX BRONCHOSCOPES MODEL EB-1570K/SERIAL: UNKNOWN. THE SCOPES WERE SUBSEQUENTLY IDENTIFIED ON (B)(6) 2009 AS: BRONCHOSCOPE MODEL 1570K/ SERIAL: (B)(4). INVESTIGATION INDICATED THAT THE CUSTOMER TESTED PENTAX SCOPE AND FOUND ADENOVIRUS. SUBSEQUENT INVESTIGATION RESULTED IN CLARIFICATION THAT THE HOSPITAL USED A TEST THAT DETECTS THE PRESENCE OF VIRAL DNA AND IT DID NOT DETERMINE THAT THE VIRUS MATERIAL OBSERVED ON THE SCOPES WAS FROM VIABLE ORGANISMS. THE FACILITY ALSO REPORTED THAT "SUCTION ARM ON EVERY SCOPE WAS LOOSE AND COULD BE TIGHTENED BY HAND." NO FURTHER INFORMATION WAS REPORTED ON THE PATIENTS. THE FACILITY SUBSEQUENTLY REPORTED THAT THE LOOSE SUCTION ARM WAS PRESENT ON EB-1970K AND VNL-1170K SCOPES AS WELL. ON OR AROUND JUNE 16, 2010, PENTAX CONFIRMED THAT THE FACILITY HAD CULTURED VIRUS FROM THE FOLLOWING PENTAX SCOPES: BRONCHOSCOPE MODEL EB-1570K/ SERIAL: (B)(4); BRONCHOSCOPE MODEL EB-1970K/SERIAL (B)(4); AND VIDEO NASOPHARYNGOSCOPE MODEL VNL-1170K/SERIAL (B)(4). NO INFORMATION WAS PROVIDED AS TO WHETHER PATIENTS WERE INVOLVED. PENTAX CONFIRMED THE CUSTOMER'S OBSERVATION OF LOOSE SUCTION ARM IN SOME OF THE SCOPES, AND DETERMINED THROUGH AN ADDITIONAL INVESTIGATION AND TREND ANALYSIS THAT CERTAIN SCOPES (INCLUDING THE EB-1570K, EB-1970K, EB-1170K, EB-1970TK, EB-1970UK, VNL1570K, AND ECY-1570K) COULD HAVE LOOSE SUCTION ARMS THROUGH ROUTINE USE AS A RESULT OF MECHANICAL FRICTION BETWEEN THE SCREW THAT HELPS SECURE THE SUCTION ARM TO THE CONTROL BODY AND THE SUCTION TUBE THREADS OVER TIME. PENTAX INITIATED REMEDIAL ACTION IN 2010 AND 2011, WHICH INCLUDED RE-EDUCATING THE FACILITY AND OTHER CUSTOMERS ON CURRENT IFUS FOR PROPER INSPECTION OF THE SUCTION ARM FOR TIGHTNESS PRIOR TO USE AND TO RETURN FOR SERVICE ANY SCOPE WITH LOOSE SUCTION ARM. PENTAX ALSO INITIATED A NOTICE OF MODIFICATION (NOM) TO APPLY EPOXY TO HELP SECURE THE SUCTION ARM (CLOSED (B)(6) 2011). PENTAX ALSO PROVIDED AN IN-SERVICE PROGRAM WHICH INVOLVED GOING ON-SITE TO CHECK FOR LOOSE SUCTION ARM AND PROVIDING IN-SERVICE TRAINING FOR AT LEAST 46% OF CUSTOMERS. PENTAX IS CONTINUING TO LOOK INTO THE SCOPE OF THE TRAINING. IN ADDITION, PENTAX BEGAN USING ADDITIONAL EPOXY DURING PRODUCTION TO HELP BETTER SECURE THE SUCTION ARM. PENTAX ADDED THE EPOXY MOVING FORWARD TO THE FOLLOWING MODELS: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK, EB-1970UK, EB-P1170K, ECY-1570, ECY-1570K, VNL-1570K, VNL-1570STK, EB-1970UBK, ECY-1571K. INSOFAR AS THE ADDITION OF THE EPOXY WAS INTENDED TO REDUCE A RISK TO HEALTH POSED BY THOSE DEVICES, IT WAS A CORRECTION WITHIN THE MEANING OF 21 CFR 806.10. PENTAX DOES NOT INTEND TO SUBMIT A SEPARATE NOTICE OF CORRECTION AS THIS MDR INCLUDES A FULL DISCLOSURE OF THE CORRECTION UNDER 21 CFR 806.10. SEPARATE MDRS ARE BEING FILED FOR EACH OF THE 9 PATIENTS. THIS REPORT IS FOR PATIENT #5 WHO TESTED POSITIVE FOR VIRUS (UNSPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19892 PENTAX SEE H10 EOQ PENTAX SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other