BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 5991011 · Received September 30, 2016

    Report

    Report Number
    9610877-2016-00158
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    July 23, 2016
    Report Date
    August 31, 2016
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    PMA / PMN Number
    K951199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MDR 9610877-2016-00159 INCLUDES INFORMATION ON THE SECOND PATIENT INVOLVED IN THE EVENT. (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT ON 08/31/2016 WHICH STATED THE FACILITY "HAD CONCERNS REGARDING THIS SCOPE RESULTING FROM 2 PATIENTS WHO HAVE CULTURED POSITIVE FOR ACREMONIUM" INVOLVING PENTAX FIBER BRONCHOSCOPE MODEL FB-15BS/G112034. THE FIBER BRONCHOSCOPE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION. THE INSPECTIONAL FINDINGS INCLUDED: RESIDUE BUILD UP ON THE SUCTION CYLINDER, BOTH THE DRY AND WET LEAK TESTS PASSED. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY ON 09/12/2016 FOR THE PATIENT AND THE DEVICE IDENTIFIED IN THIS MDR, STATED THE PATIENT DID NOT REPORT ANY SYMPTOMS OF ILLNESS, WAS NOT RECALLED FOR FURTHER SCREENING OR PROVIDED ANY TREATMENT, AND IS CURRENTLY STABLE. IN ADDITION, THE FACILITY STATED THE FIBER BRONCHOSCOPE IS NOT ROUTINELY CULTURED, AND DEPENDING ON THE CASE LOAD, REPROCESSING OF SCOPES AT THE FACILITY DOES NOT EXCEED 3 HOURS. PENTAX MEDICAL, ALONG WITH THE FACILITY, ARE CURRENTLY INVESTIGATING THIS EVENT TO DETERMINE POSSIBLE ROOT CAUSE(S).

    Additional Manufacturer Narrative · 1

    (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 1

    REPAIRS WERE PERFORMED ON THE BRONCHOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, CONTROL BODY ASSY COMPLETE, INSERTION FLEX TUBE W/SEG PB-FREE, SEGMENT STEEL BRAID, DISTAL ATTACHING PIN, OPERATION CHANNEL, BENDING RUBBER. ON 25/OCT/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. THE BRONCHOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 01/NOV/2016. 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
    642453 PENTAX FIBER BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE FB-15BS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR