BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGICAL SNARE

    MDR report key: 3170553 · Received June 6, 2013

    Report

    Report Number
    8010047-2013-00148
    Event Type
    Other
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION, BECAUSE THE FACILITY INTENDED TO USE THE SUBJECT DEVICE CONTINUOUSLY. IF REPORTABLE RESULT IS FOUND AFTER THE EVALUATION, OMSC WILL SUBMIT THE RESULT AS SUPPLEMENTAL REPORT. THE SD-5U-1 INSTRUCTION MANUAL ALREADY STATES; WARNINGS: DO NOT USE EXCESSIVE FORCE WHEN SNARING TISSUE. THIS COULD RESULT IN BLEEDING OR MUCOUS MEMBRANE DAMAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING A POLYPECTOMY UNDER COLONOSCOPY, THE USER SUCCESSFULLY CUT THE POLYP, BUT A BLEEDING OCCURRED BECAUSE THE SNARE CUT THE POLYP MECHANICALLY. THE BLEEDING WAS REPORTEDLY TREATED WITH AN UNCERTAIN CLIP ENDOSCOPICALLY. THERE WAS NO REPORT REGARDING FURTHER INJURY AND THE PROCEDURE WAS REPORTEDLY COMPLETED USING SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252007 ELECTROSURGICAL SNARE ELECTROSURGICAL SNARE FDI OLYMPUS MEDICAL SYSTEMS CORPORATION SD-5U-1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other