BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPE

    MDR report key: 494376 · Received October 27, 2003

    Report

    Report Number
    494376
    Event Type
    Injury
    Date Received
    October 27, 2003
    Date of Event
    August 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    PENTAX PRECISION INSTRUMENT CORP.
    Product Code
    GCQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE PATIENTS THAT WERE SCOPED WITH THE SAME ENDOSCOPE HAVE ALL TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA WITH AN IDENTICAL SENSITIVITY PATTERN. THE FIRST CASE WAS DONE IN 2003, THE PATIENT HAD A PSEUDOCYST THAT WAS DRAINED BY ENDOSCOPIC ULTRASOUND. A BACTERIAL CULTURE WAS DONE FROM THE ASPIRATE OBTAINED DURING THE PROCEDURE. THE PATIENT WAS READMITTED AND WAS IN THE HOSPITAL FOR 5 DAYS RECEIVING ANTIBIOTICS, AND WAS SEEN BY INFECTIOUS DISEASE, AND WAS DISCHARGED. IN THE SECOND CASE, THE PATIENT HAD EUS-FNA [ENDOSCOPIC ULTRASOUND - FINE NEEDLE ASPIRATION] DONE FOR A PANCREATIC CYST LESION. A CULTURE WAS DONE THAT WAS POSITIVE FOR PSEUDOMONAS. [THIS PATIENT DIED, DUE TO AN UNRELATED CAUSE.] THE THIRD PATIENT HAD AN EUS FNA IN 2003, RETURNED FOR ANOTHER FNA [FINE NEEDLE ASPIRATION] AND THE CULTURE GREW THE SAME PSEUDOMANAS AEURUGINOSA. MICROBIOLOGIC SAMPLING WAS DONE TO DETERMINE THE SOURCE. SIX CULTURES WERE OBTAINED. SPECIMEN A ENDOSCOPE CHANNEL-BRUSH SAMPLE GREW PSEUDOMONAS AERUGINOSA. SPECIMEN B ENDOSCOPE CHANNEL-BRUSH SAMPLE GREW PSEUDOMONAS AERUGINOSA. SPECIMEN C SWAB OF ENDOSCOPE ELEVATOR GREW STAPH. SPECIMEN D RINSE WATER - NO GROWTH. SPECIMEN E MACHINE TO SCOPE - NO GROWTH. SPECIMEN F TAP WATER IN EXAM ROOM - NO GROWTH. THE SCOPE WAS TAKEN OUT OF SERVICE, AND GASSED. IT WAS THEN RECULTURED WITH NO GROWTH. THE WASHER WAS CULTURED 3 TIMES WITH NEGATIVE RESULTS EACH TIME. THESE SCOPES ARE TYPICALLY CLEANED MANUALLY, IN ADDITION TO THE USE OF THE WASHER, AND ACCORDING TO MANUFACTURER'S INSTRUCTIONS. DURING THIS PERIOD THE DEPARTMENT WAS IN CONSTANT CONTACT WITH THE MANUFACTURER. OF A TOTAL OF 14 PATIENTS AT THE HOSPITAL INVOLVED WITH THIS DEVICE, 11 HAVE NOT YET BEEN CULTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPE LINEAR ENDOSCOPE GCQ PENTAX PRECISION INSTRUMENT CORP. EG3630U *
    2 AUTOMATIC ENDOSCOPIC REPROCESSOR WASHER LRJ ADVANCED STERILIZING PRODUCTS 387P-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * AUTOMATIC ENDOSCOPIC REPROCESSOR BETWEEN USES.| THE SCOPE WAS DISINFECTED WITH CIDEX/OPA WITH AN