BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSE ENDOSCOPY SYSTEM

    MDR report key: 5382779 · Received January 15, 2016

    Report

    Report Number
    3007591333-2016-00002
    Event Type
    Injury
    Date Received
    January 15, 2016
    Date of Event
    December 21, 2015
    Report Date
    January 15, 2016
    Manufacturer
    ENDOCHOICE INC.
    Product Code
    FDF
    PMA / PMN Number
    K141598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT WAS RETURNED TO ENDOCHOICE AND INSPECTED BY SERVICE. NO PROBLEM WAS FOUND WITH THE DEVICE.

    Description of Event or Problem · 1

    THE USERS OF THE COLONOSCOPE REPORTED THAT TEARING OF COLON TISSUE OCCURRED DURING A CASE. THE PHYSICIAN INDICATED THAT THE TISSUE DAMAGE WAS SIMILAR TO THAT WHICH MAY OCCASIONALLY OCCUR WHEN TAKING A BIOPSY. THE USE FACILITY STATED THAT THE WATER JET NOZZLE LOCATED ON THE DISTAL TIP OF THE DEVICE APPEARED TO PROTRUDE MORE THAN USUAL. THIS WAS ONE OF TWO SIMILAR REPORTS OCCURRING ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28520 FUSE ENDOSCOPY SYSTEM COLONOSCOPE AND ACCESSORIES FDF ENDOCHOICE INC. FUSE 1CS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention