BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2660949 · Received July 6, 2012

    Report

    Report Number
    2518897-2012-00006
    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 OTHER THAN THE INFO CONTAINED. 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. SUCTION IS A FUNCTION OF THE PENTAX ENDOSCOPE OR THE ANCILLARY SUCTION SOURCE (NOT SOLD BY PENTAX MEDICAL COMPANY). THE SITE DID NOT DOCUMENT THE ENDOSCOPE MODEL/SERIAL USED IN THE EVENT. THE ENDOSCOPE REMAINS IN USE AT THE FACILITY. IFU'S SUPPLIED WITH THE EQUIPMENT REQUIRE THE DEVICES BE CHECKED PRIOR TO PROCEDURE. THE SITE HAS NOT REPORTED ANY FAILURES OF ENDOSCOPES IN PRE-SYSTEM CHECKS SINCE THE EVENT, THEREFORE, WE FEEL THE EVENT WAS CAUSED BY USER ERROR; USER DID NOT PERFORM PRE-SYSTEM CHECK OF ENDOSCOPE OR DID NOT SELECT APPROPRIATE SUCTION PRESSURE SETTING FOR THE ANCILLARY SUCTION SOURCE PRIOR TO THE PROCEDURE. PENTAX CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    (B)(6) 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: INADEQUATE SUCTION TO MANAGE ESOPHAGEAL BLEED.

    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