The subject device was not returned to olympus medical systems corp.(omsc).Since the lot no.Is unknown, the manufacturing history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.From the reported information, we presume that the reported accidental symptom was not due to the malfunction of the device, but occurred as a general accidental symptom of the procedure.
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On august 7th, 2019, olympus medical systems corp.(omsc) received a literature titled ¿value of endoscopic ultrasonography in diagnosis of gastric stromal tumor and the application of endoscopic submucosal excavation in the treatment of gastric stromal tumor¿.The literature reported that 29 procedures of endoscopic submucosal dissection (esd) were performed using olympus single use electrosurgical knife (kd-620lr or kd-611l) between december 2012 and october 2013.The literature reported that symptoms occurred as follows; mild bleeding : 29 cases.They were managed by argon plasma coagulation or hot biopsy.In one case small artery ejection bleeding occurred and hemostatic clip was used to close the bleeding.Perforation: 3 cases.The users were sealed by titanium clip and/or nylon ring.All patients received diet control, gastrointestinal decompression, anti-infection and other treatments.Conservative medical treatment was successful.Omsc tried to obtain further information such as the relationship between olympus device and all of the reported symptoms, but it is not obtained from the author of this literature at present.Therefore, according to the number of the type of symptoms known and the number of olympus device used for procedure, omsc is submitting 4 medical device reports.This is a report on mild bleeding associated with kd-611l, and 3 of 4 reports.
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