BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 5088077 · Received September 11, 2015

    Report

    Report Number
    3007591333-2015-00044
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    August 17, 2015
    Report Date
    September 11, 2015
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL DEVICE WAS INSPECTED AND FOUND TO BE IN CONFORMITY W/ALL SPECIFICATIONS. IT HAS BEEN RETURNED TO USE. THE PHYSICIAN INVOLVED IN THE CASE INDICTED THAT THE ROOT CAUSE WAS LIKELY TO BE THE EXAMINATION ITSELF, FOR EXAMPLE THE REQUIRED PRESSURE INCREASE IN THE COLON VIA SUPPLY OF AIR INSUFFLATION, OR EXTERNAL PRESSURE EXERTED ON THE PT BY MANIPULATING THE PT'S ABDOMEN. THE PHYSICIAN DID NOT BELIEVE THAT THE INCIDENT WAS CAUSED BY THE SPECIFIC DEVICE.

    Description of Event or Problem · 1

    DURING A COLONOSCOPIC EXAMINATION, THE PROCEDURE PROCEEDED NORMALLY UNTIL ADVANCING TO THE CECUM. WHEN WITHDRAWING FROM THE CECUM, A PERFORATION OF THE COLON W/OUT SIGNIFICANT BLEEDING COULD BE SEEN. THE PROCEDURE WAS IMMEDIATELY STOPPED AND THE PT WAS HOSPITALIZED W/A SUSPECTED BURST DIVERTICULUM. A SURGICAL PROCEDURE WAS PERFORMED SUCCESSFULLY, AND THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601207 FUSE ENDOSCOPY SYSTEM FDF ENDOCHOICE INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization