BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 3093902 · Received April 25, 2013

    Report

    Report Number
    8010047-2013-00094
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    April 3, 2012
    Report Date
    April 4, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OMSC FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE PHYSICIAN REPORTED THAT THERE WAS NO ABNORMAL POINT ON THE SUBJECT DEVICE DURING THE PROCEDURE AND THE PERFORATION WAS LIKELY TO BE OCCURRED BECAUSE THE TISSUE OF THE LESION WAS HARD AND USER FORCIBLY PRESSED THE DISTAL END OF THE SUBJECT DEVICE TO THE TISSUE. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OMSC FOR EVALUATION BECAUSE THE FACILITY DISCARDED THE DEVICE. OMSC REVIEWED THE MANUFACTURING RECORDS OF THE SUBJECT DEVICE AND CONFIRMED THAT THERE WAS NO IRREGULARITY. THE DEVICE INSTRUCTION MANUAL WARNS USERS THAT "DO NOT FORCIBLY PRESS THE INSTRUMENT'S DISTAL END OR THE ENDOSCOPE'S DISTAL END TO TISSUE EXCESSIVELY. OTHERWISE, PERFORATIONS, PNEUMOMEDIASTINUMS, BLEEDINGS OR MUCOUS MEMBRANE DAMAGE MAY RESULT." 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 THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR TREATING A LESION IN GASTRIC ANGLE USING THE SUBJECT DEVICE, THE PHYSICIAN DECIDED THAT THE PROCEDURE CAUSED A PERFORATION IN THE STOMACH BECAUSE THE STOMACH COULD NOT BE INFLATED BY AIR FEEDING FUNCTION OF THE ENDOSCOPE. THE PATIENT WAS SAID TO HAVE TRANSFERRED TO OPEN SURGERY AND THE LESION WAS DISSECTED. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178814 SINGLE USE ELECTROSURGICAL KNIFE ELECTROSURGICAL KNIFE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION KD-650L 2ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other