BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL KNIFE

    MDR report key: 3698571 · Received March 19, 2014

    Report

    Report Number
    8010047-2014-00121
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 26, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR INVESTIGATION SINCE THE FACILITY REPROCESSED IT AND CONTINUED TO USE. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, OMSC THINKS THAT THERE WAS NO ABNORMALITY OF THE DEVICE BECAUSE THE DEVICE STILL CAN BE USED BY FACILITY. SO, OMSC CONSIDERS THAT USER HANDLING CAUSED THIS EVENT. THE DEVICE INSTRUCTION MANUAL HAS WARNED USERS THAT "DO NOT FORCE THE CUTTING KNIFE AGAINST BODY CAVITY TISSUE. THIS COULD CAUSE PT INJURY, SUCH AS PERFORATION, BLEEDING OR MUCOUS MEMBRANE DAMAGE." A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT 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 MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING REMOVAL OF FULL-THICKNESS OF STOMACH BY LAPAROSCOPY AND ENDOSCOPY COOPERATIVE SURGERY (LECS), DAMAGE OCCURRED IN DIAPHRAGM, PERICARDIUM AND CORONARY VEIN. THE DOCTOR SWITCHED OPEN SURGERY AND TREATED DAMAGED AREA SINCE BLEEDING FROM CORONARY VEIN WAS UNCONTROLLABLE. STATUS OF OCCURRENCE WAS UNSPECIFIED. THE FACILITY INFORMED THAT AFTER THE EVENT, THE PT WAS RELEASED SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165034 ELECTROSURGICAL KNIFE ELECTROSURGICAL KNIFE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION KD-1L-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention