BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7386761 · Received March 30, 2018

    Report

    Report Number
    9610877-2018-00070
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Report Date
    March 1, 2018
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HOYA CORPORATION PENTAX TOKYO OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX TOKYO OFFICE (EXEMPTION NUMBER E2015036). RESULT CODES(S): WEAR PROBLEM FDA 140. CONCLUSION CODE(S): DEVICE REPAIRED AND RETURNED FDA 63.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT STATING PENTAX MODEL ED-3490TK/SERIAL (B)(4) CULTURED POSITIVE AFTER SAMPLING PERFORMED ON (B)(6) 2018. THE SAMPLING PERFORMED ON (B)(6) 2018 YIELDED A TOTAL OF 11 CFU COMPRISED OF THE FOLLOWING 5 ISOLATES: VARIABLE RODS, PAENIBACILLUS PROVENCENSIS. POSITIVE RODS, BACILLUS SPECIES. POSITIVE COCCI, STAPHYLOCOCCUS EPIDERMIS. VARIABLE RODS, TERRIBACILLUS GORIENSIS. VARIABLE RODS, BACILLUS SPECIES. THE DUODENOSCOPE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION. THE PENTAX MEDICAL SERVICE INSPECTION FINDINGS INCLUDED THE FOLLOWING: SEGMENT STEEL BRAID CUT. DISTAL CAP-FIXED TYPE PASSED SEAL INTEGRITY INSPECTION. PASSED WET/DRY LEAK TEST. REPAIRS WERE PERFORMED ON THE DUODENOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: BIOPSY INLET T-PIECE PB-FREE. AIR/WATER TUBE. DEFLECTOR BODY. DEFLECTOR BODY LINK. DEFLECTOR OPERATING WIRE. OPERATION CHANNEL. BENDING RUBBER. DISTAL CASE/CAP. ADJUSTING COLLAR. SEGMENT ATTACHING SCREW. DISTAL CASE ATTACHING SCREW. SEGMENT ASSY ATTACHING SCREW. STAYCOIL COLLAR. SEGMENT STAYCOIL ASSY IMP-C/PB-FREE. RL AND UD PULLEY ASSY.

    Description of Event or Problem · 0

    AFTER COMPLETION OF ALL INSPECTION AND REPAIRS, THE DUODENOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 04/17/2018 UNDER THE REFERENCE DELIVERY NUMBER (B)(4). ON 05/18/2018, A DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING THE ENDOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, HOWEVER IT FAILED DURING FINAL INSPECTION (SCRATCH AT THE IFT). IT WAS REWORKED WHERE THE IFT (INSERTION FLEXIBLE TUBE). WAS EXCHANGED AND IT PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. PENTAX ED-3490TK/SERIAL (B)(4) HAS BEEN ROUTINELY SERVICED BY A PENTAX FACILITY SINCE THE DEVICE WAS SHIPPED TO THE CUSTOMER ON 12/13/2012. CORRECTIVE ACTION (B)(4), WAS INITIATED ON 10 APR 2018 FOR A SAMPLING AND CULTURING STUDY TREND AND IS STILL IN THE INVESTIGATION PROCESS. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229495 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1