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 lot 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 was no description of the device's malfunction.
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On june 29, 2020, olympus medical systems corp.(omsc) received literature titled "original article safety of endoscopic submucosal dissection for gastrointestinal neoplasms:risk of thrombosis".In the literature, it was reported that perforation was observed in 14 patients with the endoscopic submucosal dissection (esd).We do not found that what the severity of these perforations is and also whether these perforations could be completely closed or not.The esd procedure was performed using the single use electrosurgical knife (a flex-knife, and an insulation-tipped diathermy knife).The model number was not identified.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.However, the literature indicated that the perforation associated with esd.Therefore, omsc will submit 14 medical device reports (mdr) for each incomplete closure event.This report is 6 of 14 reports for the intraoperative perforation of the single use electrosurgical knife.
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