BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTAX

    MDR report key: 1938982 · Received December 27, 2010

    Report

    Report Number
    2518897-2010-00002
    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
    FDF
    PMA / PMN Number
    K951574
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EC-3490LK INSTRUCTIONS FOR USE CONTAIN PRE - AND POST-PROCEDURE INSPECTION. THE EC-3490LK WAS PLACED BACK INTO USE BY THE USER FACILITY AFTER THE EVENT. THE FACILITY DID NOT REPORT THE EVENT TO THE DEVICE DISTRIBUTOR AT THE TIME OF THE EVENT. THE EC-3490LK WAS SENT TO THE DISTRIBUTOR FOR ROUTINE REPAIR ON (B)(6) 2010 AND THE USER FACILITY DID NOT INDICATE THAT THE DEVICE HAD BEEN INVOLVED IN AN ADVERSE EVENT. EVAL SUMMARY - FAILURE - RIGHT/LEFT ANGULATION BROKEN. OTHER FINDINGS - NORMAL WEAR AND TEAR.

    Description of Event or Problem · 1

    ON (B)(6) 2010 - PT REFERRED TO AMBULATORY SURGERY CENTER WITH ABDOMINAL PAIN. UPPER AND LOWER GI ENDOSCOPIC PROCEDURES WERE 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 COLONOSCOPE FDF PENTAX MEDICAL COMPANY EC-3490LK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death