BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 6430024 · Received March 23, 2017

    Report

    Report Number
    9610877-2017-00015
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 21, 2017
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    PMA / PMN Number
    K131946
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    REPORT SOURCE CONTINUED: 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). RESULTS CODES: WEAR PROBLEM FDA 140. CONCLUSION CODES: USE ERROR CAUSED OR CONTRIBUTED TO EVENT FDA 61. DEVICE REPAIRED AND RETURNED FDA 63.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT WHICH STATED ULTRASOUND VIDEO BRONCHOSCOPE MODEL EB-1970UK/SERIAL (B)(4) WAS INTRODUCED INTO THE PATIENT AND A BIOPSY NEEDLE WAS ATTEMPTED TO BE PASSED, THOUGH UNSUCCESSFUL. DURING THIS TIME, BLOOD WAS NOTICED IN THE PATIENT. THE BRONCHOSCOPE WAS REMOVED FROM THE PATIENT. THE USER FOUND THAT THE TRANSDUCER ON THE BRONCHOSCOPE SEEMED RAISED AND HAD ROUGH EDGES. WHILE THE BRONCHOSCOPE WAS OUT OF THE PATIENT, THE BIOPSY NEEDLE WAS PASSED SUCCESSFULLY AND THE BRONCHOSCOPE WAS THEN REINTRODUCED INTO THE PATIENT WITH THE BIOPSY NEEDLE IN PLACE AND THE BIOPSY WAS ATTEMPTED. DURING FLUSHING OF THE BRONCHOSCOPE POST-PROCEDURE, THE NURSING STAFF AND PHYSICIAN NOTED DEBRIS, DESCRIBED AS RESEMBLING BLOOD, BLACK PARTICLES, METALS, AND POSSIBLE GLASS PARTICLES. SAMPLES OF THE DEBRIS WERE SENT TO PATHOLOGY FOR EVALUATION. THE DEVICE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION. THE PENTAX MEDICAL SERVICE INSPECTION FINDINGS INCLUDED THE FOLLOWING: -LEAK AT BIOPSY CHANNEL (LARGE/PRIMARY) DISTAL SIDE -FAILED DRY/WET LEAK TESTS -LIGHTGUIDE PRONG COVER GLASS SET LOOSE -BALLOON INJECTION TUBE CLOGGED (NO FLOW) -ULTRASOUND CONNECTOR BODY CORROSION ON MAIN CIRCUIT BOARD -SHIELD COVER CORRODED THE DIELECTRIC STRENGTH TEST AND SUCTION FUNCTION TEST WERE NOT PERFORMED DUE TO THE COMPROMISED CONDITION OF THE DEVICE. THE DEVICE IS CURRENTLY UNDERGOING REPAIRS. PENTAX MEDICAL MADE GOOD FAITH EFFORTS TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT AND THE PATIENT INVOLVED. THE FACILITY DECLINED TO PROVIDE ANY PATIENT INFORMATION OR PATIENT STATUS. HOWEVER, THE FACILITY DID CONFIRM THERE WAS NO DELAY IN THE PROCEDURE AND NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    PENTAX MEDICAL NOTIFIED THE MANUFACTURE QA TEAM REGARDING THIS EVENT AND THE MANUFACTURE HAD ADDITIONAL FOLLOW UP QUESTIONS FOR THE END USER. ON 10/MAR/2017, PENTAX TERRITORY MANAGER NOTIFIED PENTAX MEDICAL AND THE MANUFACTURE THAT HIS CONTACTS AT THE FACILITY DECLINE TO ANSWER HIS QUESTIONS DUE TO HIPPA AND REFERRED HIM TO RISK MANAGEMENT DEPARTMENT. HE STATED HE MADE NUMEROUS CALLS DAILY TO THE RISK MANAGEMENT DEPARTMENT AND LEFT VOICEMAILS REQUESTING A CALL BACK AND ALSO EXPLAINED PENTAX'S DEADLINE FOR REPORTING, HOWEVER HIS CALLS WERE UNANSWERED AND NOT RETURNED. SINCE GOOD FAITH EFFORT INFORMATION RECEIVED WAS LIMITED, THE INVESTIGATION WAS CONDUCTED ON OBJECTIVE EVIDENCE AND BASED ON THE INSPECTION FINDINGS THE TRANSDUCER RUBBER WAS FULLY INTACT, THERE WERE NO RAISED OR ROUGH EDGES ON THE TRANSDUCER. SINCE THERE WAS A LEAK FOUND IN THE CHANNEL IT IS REASONABLE TO CONCLUDED THIS WAS A USER INFLECTED DAMAGE DUE TO THE USER STATING THAT PRE-PROCEDURE INSPECTION WAS PERFORMED BY THE NURSING STAFF AND PHYSICIAN PRIOR AND LEAK TEST IN CSR(CENTRAL STERILIZATION ROOM) PRIOR WHICH PASSED. A REVIEW OF THE SERVICE HISTORY INDICATES THE BRONCHOSCOPE WAS TESTED AND ALL FUNCTION PASS WHICH INCLUDES THE LEAK TEST. IN ADDITION THE BRONCHOSCOPE WAS WAS ROUTINELY SERVICE BY PENTAX SINCE STARTUP OF 06/JAN/2014. A DEVICE HISTORY REVIEW WAS PERFORMED ON 17/MAR/2018 CONFIRMING THE BRONCHOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. AS PER INSTRUCTIONS FOR USE(IFU), "E) ANY ACCESSORY SHOULD BE SLOWLY INSERTED THROUGH THE INSTRUMENT CHANNEL INLET WITH THE ENDOSCOPE IN A STRAIGHT POSITION. THERE SHOULD BE NO RESISTANCE ENCOUNTERED. IF RESISTANCE IS ENCOUNTERED, DO NOT ATTEMPT TO INTRODUCE THE ACCESSORY FURTHER. THE INSTRUMENT CHANNEL MAY BE DAMAGED AND THE ENDOSCOPE SHOULD NOT BE USED. CONTACT THE PENTAX SERVICE DEPARTMENT." GIVEN THE ABOVE STATEMENT IN THE IFU AND THE INVESTIGATION PERFORMED, ITS REASONABLE TO CONCLUDE THE CAUSE OF THIS EVENT IS USER ERROR BY NOT FOLLOWING THE IFU. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION REGARDING THIS EVENT AND THEREFORE, PENTAX MEDICAL CLOSED THIS COMPLAINT ON 06JUN2018 AND CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209913 PENTAX ULTRASOUND VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB-1970UK

    Patients

    Seq Age Sex Outcome Treatment
    1