BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7379548 · Received March 28, 2018

    Report

    Report Number
    9610877-2018-00105
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Report Date
    February 26, 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). EVALUATIONS CODES: METHOD CODES: ACTUAL DEVICE EVALUATED FDA 10. RESULTS CODES: WEAR PROBLEM FDA 140. CONCLUSION CODES: 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 (B)(6) AFTER SAMPLING PERFORMED ON (B)(6) 2018. THE SAMPLING PERFORMED ON (B)(6) 2018 YIELDED A TOTAL OF 15 CFU COMPRISED OF THE FOLLOWING 8 ISOLATES: (B)(6) RODS, BACILLUS SIMPLEX, (B)(6) COCCI, BACILLUS AMYLOLIQUEFACIENS, (B)(6) RODS, (B)(6), (B)(6) RODS, BACILLUS HALOSACCHAROVORANS, (B)(6) RODS, BACILLUS IDRIENSIS, (B)(6) COCCI, (B)(6), (B)(6) RODS, BACILLUS HALOSACCHAROVORANS, (B)(6) COCCI, MORAXELLA OSLOENSIS. THE DUODENOSCOPE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION.

    Description of Event or Problem · 0

    ON 03/15/2018 PENTAX OF AMERICA, INC(PAI) CUSTOMER SERVICE ISSUED A RMA NUMBER (B)(4) FOR THE DUODENOSCOPE TO BE RETURNED TO PENTAX MEDICAL FOR EVALUATION. ON 03/26/2018 THE DUODENOSCOPE WAS INSPECTED BY A PAI TECHNICIAN UNDER THE SERVICE ORDER NUMBER 3109107. THE PENTAX MEDICAL SERVICE INSPECTION FINDINGS INCLUDED THE FOLLOWING: INSERTION TUBE GAUGE/DIG AT STAGE 1. AIR/WATER SOCKET CYLINDER O-RING CHIPPED. AIR/WATER DELIVERY FUNCTION AIR MIXED WITH WATER DELIVER. PASSED WET/DRY LEAK TEST. SUCTION TUBE MILD RESISTANCE. AFTER COMPLETION OF ALL INSPECTION AND REPAIRS, THE DUODENOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 04/24/2018 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 (ANGLE PART INDENTATION). IT WAS REWORKED WHERE ANGLE WIRE READJUSTMENT WAS DONE 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 MODEL 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 04/10/2018 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
    222461 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1