The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.
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On february 2, 2021, olympus medical systems corp.(omsc) received the literature titled "learning curve for endoscopic submucosal dissection of esophageal neoplasms".This study was conducted on the endoscopic submucosal dissection (esd) for 27 patients with esophageal neoplasms between january 2012 to november 2014.In the literature, it was reported 2 patients of significant bleeding during the procedure.Both patients had liver cirrhosis and esophageal varices.Frequent bleeding occurred during mucosal incision and submucosal dissection, resulting in prolonged procedure times of 327 min and 332 min for these two patients due to most of the time was spent on hemostasis.Based on the available information, these two bleeding were not reported in a direct relationship with the olympus products.However, omsc assumes that these events might be related to the subject device since the subject device was used for mucosal incision and submucosal dissection.There is no description of the device's malfunction.Omsc will submit one medical device reports (mdr) of the subject device for significant bleeding which prolonged procedure times.
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