BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 8083994 · Received November 19, 2018

    Report

    Report Number
    8083994
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    September 21, 2018
    Report Date
    November 9, 2018
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    FDF
    UDI-DI
    04953170305214
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR COLONOSCOPY, PED. COLONIC SCOPE WAS USED AND INTACT. SCOPE WAS INSERTED WITHOUT DIFFICULTY. UPON WITHDRAW TRAUMA NOTED TO MUCOSA. SCOPE PLACED ON TABLE INSPECTED AND NOTED CRACK/TEAR TO THE SCOPE. DR. NOTIFIED OF SCOPE DAMAGE. AFTER BEING IN THE SEDATION, THE PATIENT WAS PLACED IN THE LEFT LATERAL DECUBITUS POSITION. THE VIDEO OLYMPUS PEDIATRIC COLONOSCOPE WAS USED FOR PROCEDURE. A DIGITAL EXAM WAS PERFORMED. NO PURULENCE NOTED. THE SPHINCTER TONE WAS GOOD. NO MASS LESIONS PALPATED. NEXT, PEDIATRIC OLYMPUS COLONOSCOPE WAS INTRODUCED THROUGH THE ANAL OPENING. SCOPE WAS TRAVERSED THROUGH THE TORTUOUS SPASTIC COLON, UP TO THE 25 CM LEVEL WHERE THE EXAMINATION OR AT THIS POINT, THERE IS MARKED TORTUOSITY AND ANGULATION, SCOPE WAS NOT ADVANCED ANY FURTHER. SCOPE WAS THEN BROUGHT BACK. AIR WAS SUCTIONED OUT. NO WAS MADE OF SOME HYPEREMIC AREA JUST DISTAL TO THE SCOPE ADVANCEMENT WITH SUPERFICIAL MUCOSAL TEAR NOTED IN THE SIGMOID AS WELL AS IN THE RECTAL AREA. NO OTHER ABNORMALITIES ENDOSCOPICALLY NOTED. THE MUCOSA WAS VERY FRIABLE AND ATTEMPTS WERE MADE TO RETROFLEX, HOWEVER, WERE UNSUCCESSFUL. AT THIS POINT, THE SCOPE WAS WITHDRAWN. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO APPARENT COMPLICATIONS AND WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. GOOD SEDATION WAS ACHIEVED DURING PROCEDURE AND THE PATIENT HAD ADEQUATE PREP. CONTINUOUS BLOOD PRESSURE, PULSE OXIMETRY AS WELL AS CARDIAC MONITORING WAS CARRIED OUT THE PROCEDURE. THE PATIENT MAINTAINED STABLE VITAL SIGNS, CARDIAC RHYTHM, OXYGEN SATURATIONS IN THE 90-100% RANGE ON SUPPLEMENTAL NASAL CANNULA. PHOTODOCUMENTATION WAS OBTAINED. IMPRESSION: 1. TORTUOUS SPASTIC COLON, UNABLE TO ADVANCE THE SCOPE BEYOND 25 CM. SCOPE WAS INSPECTED PRIOR TO COLONOSCOPY AS IS OUR STANDARD PROCEDURES-SCOPE WAS INTACT. AFTER A DIFFICULT, INCOMPLETE COLONOSCOPY, SCOPE WAS REMOVED AND FOUND TO HAVE TORN APART. OLYMPUS PCF-H190 S/N (B)(4) SCOPE PREVIOUSLY WENT OUT TO STERIS IMS(INSTRUMENT MANAGEMENT SERVICES) FOR REPAIR OF A HOLE AT THE DISTAL END. SCOPE WAS RETURNED 3 MONTHS PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924955 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF OLYMPUS SURGICAL TECHNOLOGIES AMERICA OLYMPUS PCF-H190I 04953170305214

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Other