BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8010047-2014-00687

    MDR report key: 4280847 · Received November 18, 2014

    Report

    Report Number
    8010047-2014-00687
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    September 28, 2014
    Report Date
    January 15, 2016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. BASED UPON THE EVALUATION OF THE SUBJECT DEVICE BY OMSC, IT WAS CONFIRMED THAT THERE WERE FOREIGN SUBSTANCES IN THE OPENING OF THE INSTRUMENT CHANNEL AND IN THE SUCTION CYLINDER. THERE WAS NO ABNORMALITY SUCH AS BREAKAGE, DEFORMATION OR SCRATCHES AT THE DISTAL PART, IN THE CHANNEL, IN THE INSTRUMENT CHANNEL, INSTRUMENT CHANNEL PORT OR SUCTION CYLINDER. THE FORCEPS/IRRIGATION PLUG ENCLOSED WITH THE SUBJECT DEVICE WAS CHECKED AND THERE WAS A MARKED FOREIGN SUBSTANCE. THE FACILITY REPROCESSES THE FORCEPS/IRRIGATION PLUG WITHOUT DETACHING FROM THE SCOPE AND THIS DOES NOT CONFORM TO THE WRITTEN INSTRUCTION MANUAL. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES RELATED TO THIS PROBLEM. BASED ON THE FINDINGS, INAPPROPRIATE HANDLING BY THE USER COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR OF THE EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. PLEASE CROSS REFERENCE WITH MANUFACTURE REPORT NUMBERS, 8010047-2014-00685 AND 8010047-2014-00686.

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS COR. (OMSC) WAS INFORMED THAT AFTER EXAMINATION OF BLADDER WITH THE SUBJECT SCOPE, THE PATIENT DEVELOPED INFECTION. HE HAD AN INSPECTION ON (B)(6) IN 2014. SINCE HE DEVELOPED A FEVER AND MICTURITION PAIN FROM FOLLOWING DAY, HE VISITED THE FACILITY AND WAS DIAGNOSED WITH ACUTE PROSTATE INFLAMMATION. THE FOLLOWING DAY, HE WAS HOSPITALIZED. THE FACILITY SUPPOSED THAT SINCE HE WAS PRESCRIBED AN ANTIBIOTIC, HE HAD A NEGATIVE TEST RESULT FOR BACTERIA. ON (B)(6) IN 2014, OLYMPUS VISITED THE FACILITY TO OBTAIN DETAIL INFORMATION AND CHECK THE REPROCESS PROCEDURE. IT WAS REVEALED THAT THE FACILITY REPROCESSED A SCOPE WITHOUT DETACHING A FORCEPS/IRRIGATION PLUG. SINCE THEN, TWO SCOPES OF CYF-VA2 AND TWO FORCEPS/IRRIGATION PLUGS HAD CULTIVATION SURVEY. AS A RESULT OF SURVEY, NO BACTERIUM WAS FOUND FROM THE TWO SCOPES BUT PSEUDOMONAS AERUGINOSA WAS FOUND FROM ONE OF TWO FORCEPS/IRRIGATION PLUGS. THERE IS NO TRACKING DATA OF WHICH PLUG WAS USED FOR THE PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other