BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2840618 · Received October 24, 2012

    Report

    Report Number
    2518897-2012-00011
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 24, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    EOQ
    PMA / PMN Number
    K081518
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, PENTAX QUALITY CONTROL INSPECTOR WAS INSPECTING ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK, S/N# (B)(4), WHICH WAS RETURNED FROM (B)(6), AND FOUND A BRUSH FRAGMENT STUCK IN THE SUCTION CHANNEL OF THE SCOPE. THE SCOPE WAS INITIALLY RECEIVED AT (B)(6) ON (B)(6) 2012 AS A LOANER AND WAS RETURNED TO PENTAX ON (B)(4) 2012. THERE WAS NO CUSTOMER COMPLAINT ASSOCIATED WITH THE RETURNED SCOPE. PENTAX SALES REP COMMUNICATED THE FINDING OF THE BRUSH FRAGMENT ALONG WITH A PICTURE OF THE BRUSH FRAGMENT TO (B)(6) AND THE FACILITY STATED THAT THE HOSP WAS NOT AWARE THAT AN ACCESSORY WAS STUCK IN THE SCOPE. MOREOVER, BASED ON THE PICTURES TAKEN OF THE BRUSH FRAGMENT BY PENTAX QUALITY CONTROL INSPECTOR, THE FACILITY STATED IT IS NOT A CYTOLOGY BRUSH AND DOES NOT LOOK LIKE ANY CLEANING BRUSH OF PENTAX OR ANOTHER BRAND THAT HAS BEEN USED AT THEIR FACILITY OR OTHER (B)(6). THE HOSP CONFIRMED THAT THEY USE PENTAX TRI-BRISTLE DISPOSABLE LONG BRUSH AND PENTAX METAL REUSABLE SHORT BRUSH FOR BRONCHOSCOPES. IN ADDITION, THE FACILITY USES THE MID-SIZE PENTAX WIRE BRUSH FOR CLEANING THE SECTION BETWEEN THE SUCTION VALVE CYLINDER AND BIOPSY INLET PORT. (B)(6) ALSO STATED THAT APPROX 8-10 PROCEDURES WERE PERFORMED USING THE BRONCHOSCOPE WITH THE BRUSH POTENTIALLY STUCK INSIDE THE SUCTION CHANNEL OF THE SCOPE UNBEKNOWNST TO THE STAFF. AS PART OF THE CONTAINMENT PLAN, IN ORDER TO DETERMINE THE ORIGIN OF THE BRUSH FRAGMENT FOUND IN THE SCOPE AND THE EXTENT OF PTS EXPOSED TO THE SCOPE WITH THE BRUSH FRAGMENT STUCK INSIDE, PENTAX IS IN THE PROCESS OF IDENTIFYING THE CUSTOMERS WHO HAVE RECEIVED THE BRONCHOSCOPE EB-1970UK, S/N # (B)(4) AND INQUIRING THE CUSTOMERS IF THEY UTILIZE THE TYPE OF BRUSH FOUND IN THE SCOPE AT THEIR FACILITY. AS OF (B)(4) 2012, PENTAX HAS REPAIRED THE BRONCHOSCOPE AND ENSURED THE SCOPE IS FIT FOR ITS INTENDED USE AND HAS BEEN SENT TO ANOTHER FACILITY AS A LOANER.

    Description of Event or Problem · 1

    (B)(6) RETURNED LOANER SCOPE ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK (S/N: (B)(4)) TO PENTAX MEDICAL AND DURING INSPECTION OF THE LOANER SCOPE, PENTAX QUALITY CONTROL INSPECTOR NOTICED A WHITE BRUSH FRAGMENT WAS STUCK IN THE SUCTION CHANNEL OF THE SCOPE. THE STAFF AT (B)(6) WERE NOT AWARE AN ACCESSORY WAS LODGED INSIDE THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX ULTRASOUND VIDEO BRONCHOSCOPE EOQ PENTAX MEDICAL COMPANY EB-1970UK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BRUSH FRAGMENT