BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENTAX

    MDR report key: 65291 · Received September 9, 1996

    Report

    Report Number
    65291
    Event Type
    Other
    Date Received
    September 9, 1996
    Date of Event
    August 28, 1996
    Report Date
    September 9, 1996
    Manufacturer
    PENTAX
    Product Code
    FBN
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HEAVILY SEDATED FOR ERCP. DURING THE COURSE OF THE PROCEDURE, CAUTERY BY SITTING UP. VIDEO PROCESSOR ALSO BECAME BLANK AT THAT TIME. SCOPE RETURNED TO MFR FOR EVALUATION. CAUTERY EVALUATED BY BIOMED AND FOUND TO BE IN GOOD WORKING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX ERCP SCOPE FBN PENTAX ED3410 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other CAUTERY