Since the subject device was discarded by the user, the subject device was not returned to olympus medical systems corp (omsc) for evaluation.The lot no.Was unknown.Therefore, as the result of checking the manufacturing record over the past one year from october 17, 2016 (delivery date), there was nothing abnormal detected.The exact cause could not be conclusively determined.However, based on similar cases in the past, omsc presumes that the event occurred due to any of the following possible causes.The high frequency setting value was too high; the activation time was too long the subject device was activated without aspirating fluids adhering to the electrode, cutting knife, tube, and tissue in a body; the endoscope was abruptly angulated while activating; the subject device was activated while forcibly pressing an electrode, a cutting knife to the tissue; the tissue was deeply dissected more than necessary.The instruction manual of the subject device warns; when the electrosurgical unit is used in the coagulation mode, crack/detachment of the tip and the electrode or deformation/break of the cutting knife could occur, for example when the high-frequency output is set too high or the length of the contact between the cutting knife and tissue is too short.During treatment, always ensure that the slider slides on the handle smoothly and that the electrosurgical knife observed in the endoscopic image is normal.Should cracks or detachment of the tip or deformation/break of the cutting knife be detected during use, immediately shut off the power supply, discontinue the procedure, pull the slider and withdraw the endoscope from the patient with the cutting knife retreated in the insertion portion of this instrument.Do not continue using an abnormal electrosurgical knife to prevent perforation or hemorrhages.If the tip or cutting knife is detached be sure to collect it using grasping forceps.
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During an endoscopic submucosal dissection, it was informed that the doctor perforated the gastric fundus of the patient.The doctor sutured the perforated site with the clip.The intended procedure was stopped.After the patient had computerized tomography, he underwent surgery.The patient was hospitalized, and he is recovering at present.
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