Olympus medical systems corp.(omsc) received a literature titled, "retrospective analysis of the outcomes of endoscopic submucosal dissection for the diagnosis and treatment of subepithelial lesions in a center with high expertise." this study aimed to assess the diagnostic and therapeutic utility of endoscopic submucosal dissection (esd) for the management of subepithelial lesions (sels) in a tertiary esd referral center.A total of 634 esds were reviewed, 55 (9%) were performed in sels, (6 in the esophagus, 34 in the stomach, and 15 in the rectum).Neuroendocrine tumors, gastrointestinal stromal tumors, and granular cell tumors accounted for 38% of the procedures, with a 100% rate of en bloc resection and 65% of r0 resection; the main criterion for non-curative resection was a deep positive margin, and none of the patients treated with complementary surgery had lesions on the gastrointestinal wall.The reasons for esd in these lesions were the uncertainty of the diagnosis after eus evaluation and, in 1 case, also the lesion growth between 2 eus (anectopic pancreas).Esd can be an effective treatment for sels, even with lower curative rates comparing to procedures on epithelial lesions.Type of adverse events/number of patients¿ perforation (granular cell tumor in the esophagus, closure with endoscopic clipping) (1 patient) bleeding after discharge needing readmission (1 patient) needed hemostasis with clips during esd (1 patients) delayed bleeding (2 patients) patient identifiers: (b)(6) - dual-knives (kd-650l (single use electrosurgical knife kd-650)) (b)(6) insulated tip (it)-2 (kd-611l (single use electrosurgical knife)) (b)(6) - it-nano knives (kd-612l (single use electrosurgical knife kd-612)) (b)(6) - coagrasper (fd-410lr (single use electrosurgical hemostatic forceps)) (b)(6) - high definition endoscopes (gif-h180 (evis exera ii gastrointestinal videoscope)) (b)(6)- high definition endoscopes (gif-h190 (evis exera iii gastrointestinal videoscope)) this report is for (b)(6).
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This supplemental report is being submitted to provide additional information from the author and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5 and h6.The device history record was unable to be reviewed for this device since as a serial number was not provided.Based on the results of the investigation, it is likely the reported event is an accident, or a complication associated with a surgical procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.
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