BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTAX

    MDR report key: 1938981 · Received December 27, 2010

    Report

    Report Number
    2518897-2010-00001
    Event Type
    Death
    Date Received
    December 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    December 12, 2010
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDS
    PMA / PMN Number
    K962897
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EG-2990I INSTRUCTIONS FOR USE CONTAIN PRE - AND POST-PROCEDURE INSPECTION. THE EG-2990I WAS PLACED BACK INTO USE BY THE FACILITY AFTER THE EVENT. THE FACILITY DID NOT REPORT THE EVENT TO THE DEVICE DISTRIBUTOR AT THE TIME OF THE EVENT. EG-2990I WAS SENT TO THE DISTRIBUTOR FOR ROUTINE REPAIR ON (B)(6) 2010 USER FACILITY DID NOT INDICATE THE DEVICE HAD BEEN INVOLVED IN AN ADVERSE EVENT. DISTRIBUTOR EVAL OF RETURNED DEVICE SUMMARY: EG-2990I (B)(6) 2010. FAILURE - BITE MARK, DEVICE FAILED LEAK TEST. OTHER FINDINGS - FLUID INVASION, MISCELLANEOUS WEAR AND TEAR.

    Description of Event or Problem · 1

    ON (B)(6) 2010 - PT REFERRED TO AMBULATORY SURGERY CENTER WITH ABDOMINAL PAIN. UPPER/LOWER GI ENDOSCOPIC PROCEDURES PERFORMED. PT SENT HOME. ON (B)(6) 2010 - PT ADMITTED TO HOSPITAL WITH ABDOMINAL PAIN. LAB WORK NORMAL. PT HELD FOR OBSERVATION. ON (B)(6) 2010 - PT WAS SEPTIC. ON (B)(6) 2010 - PT DIED OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO GASTROSCOPE FDS PENTAX MEDICAL COMPANY EG-2990I

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death