BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 2041295 · Received March 25, 2011

    Report

    Report Number
    8010047-2011-00062
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE PATIENT WAS UNDER CLINICAL OBSERVATION FOR TWO OR THREE DAYS IN A STABLE CONDITION AND WAS SUBSEQUENTLY DISCHARGED. THE INVESTIGATION FOUND THAT THE SETTING OF THE ELECTROSURGICAL UNIT WAS NOT IN THE ENDO CUT MODE AS EXPECTED. IT WAS DETERMINED THAT THE AIR LEAK WAS CAUSED BY EXCESSIVE DELIVERY OF CURRENT DURING THE PROCEDURE. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THIS REPORT WILL BE SUPPLEMENTED IF RELEVANT AND SIGNIFICANT ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A DAY AFTER A PATIENT UNDERWENT A THERAPEUTIC COLON POLYPECTOMY PROCEDURE, A CT SCAN EXAMINATION WAS PERFORMED AND DETECTED AN AIR LEAK IN THE COLON. THE SUBJECT DEVICE OF THIS REPORT WAS SAID TO HAVE BEEN USED DURING THE PROCEDURE. THE SITE OF THE POLYPECTOMY HAS ALSO REPORTEDLY BEEN TREATED WITH AN UNIDENTIFIED MODEL OF HEMOCLIP. A HEMORRHAGE WAS SAID TO HAVE BEEN ARRESTED WITH AN UNSPECIFIED HEMOSTATIC CLIP DURING THE PROCEDURE. THE PATIENT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS DISPOSABLE ELECTROSURGICAL SNARE ELECTROSURGICAL SNARE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION SD-210U-25 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention UNKNOWN MODEL ERBE ELECTROSURGICAL UNIT| UNIDENTIFIED MODEL OF HEMOSTATIC CLIP