BEUDAMED
    FDA Adverse Event Other Summary report: N

    TJF-100

    MDR report key: 89501 · Received May 8, 1997

    Report

    Report Number
    2429304-1997-00014
    Event Type
    Other
    Date Received
    May 8, 1997
    Date of Event
    March 6, 1997
    Report Date
    May 8, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON WITHDRAWAL OF THE DUODENOVIDEOSCOPE AFTER THE ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY PROCEDURE, A BURN WAS NOTICED ON THE DUODENAL WALL OF THE PATIENT. A BIOPSY OF THE AFFECTED AREA WAS TAKEN AND RESULTS OF THE BIOPSY CONCLUDED THAT THE TISSUE WAS NORMAL. ALTHOUGH NO TREATMENT WAS REQUIRED, THE PATIENT, WHO HAD A PRE-EXISTING CONDITION OF PANCREATITIS AND CHOLELITHIASIS, REMAINED IN THE HOSPITAL SINCE PATIENT ROUTINELY REMAIN IN THE HOSPITAL FOR 24 HOURS FOLLOWING SPHINCTEROTOTOMY. ANOTHER CO'S CAUTERY UNIT USED DURING THE PROCEDURE WAS CHECKED AT THE HOSPITAL BY A HOSPITAL BIO-MEDICAL TECHNICIAN FOLLOWING THE PROCEDURE AND WAS RETURNED TO SERVICE SINCE NO PROBLEMS WERE FOUND. THE NURSE DID NOT KNOW THE CAUTERY SETTINGS USED DURING THE PROCEDURE. THE MICROVASIVE SPHINCTEROTOME WAS NOT CHECKED FOLLOWING THE PROCEDURE SINCE IT WAS DISPOSABLE AND HAD ALREADY BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TJF-100 TJF-100 DUODENOVIDEOSCOPE FDT THE OLYMPUS OPTICAL CO. TJF-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other