BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2660938 · Received July 6, 2012

    Report

    Report Number
    2518897-2012-00005
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Date of Event
    June 9, 2012
    Report Date
    July 6, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE INITIALLY REPORTED THE EVENT WITH NO OTHER DETAILS. THE SITE REPORTED THE EVENT OCCURRED ON THE WEEKEND OF (B)(6) 2012 BUT DID NOT SPECIFY THE DATE THIS EVENT OCCURRED. PENTAX CONTACTED THE SITE 3 TIMES TO SECURE ADD'L DETAILS OF THE EVENT, HOWEVER, TO DATE, NO FURTHER INFO HAS BEEN RECEIVED. INSUFFLATION IS A FUNCTION OF THE ENDOSCOPE OR THE VIDEO PROCESSOR, WHICH IS A REQUIRED ACCESSORY OF THE ENDOSCOPE. THE SITE DID NOT DOCUMENT THE ENDOSCOPE MODEL/SERIAL OR VIDEO PROCESSOR MODEL/SERIAL USED IN THE EVENT. THE EQUIPMENT REMAINS IN USE AT THE FACILITY. IFUS SUPPLIED WITH THE EQUIPMENT REQUIRE THE DEVICES BE CHECKED PRIOR TO PROCEDURE. THE SITE HAS NOT REPORTED ANY FAILURES OF ENDOSCOPES OR VIDEO PROCESSORS IN PRE-SYSTEM CHECKS SINCE THE EVENT, THEREFORE, WE FEEL THE EVENT WAS CAUSED BY USER ERROR; USER DID NOT SELECT APPROPRIATE AIR PRESSURE SETTING FOR THE PROCEDURE. PENTAX CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    (B)(6), VICE PRESIDENT OF PERIOPERATIVE SERVICES. (B)(6) HOSPITAL REPORTED: WE RECEIVED A PHONE CALL FROM DR (B)(6) REGARDING MALFUNCTION OF A PENTAX SCOPE WITH EMERGENCY PT/PROCEDURE PERFORMED ON THE WEEKEND. FUNCTIONAL ISSUE: FAILURE TO PRODUCE AIR (INSUFFLATIONS) LEADING TO ASPIRATION OF STOMACH CONTENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO GASTROSCOPE FDS PENTAX MEDICAL COMPANY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK