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 january 14, 2021, olympus medical systems corp.(omsc) received literature titled "source: japan endoscopy database (jed) project: a multicentre registry database of endoscopic retrograde cholangiopancreatography-related procedures".The purpose of the literature was to evaluate a multi-centre ercp-related procedure data registration system.In the literature, it was reported that 3 serious infections were observed of 4104 patients experienced ercp at kitasato university, saitama medical university international medical center, toranomon hospital and jikei medical university katsushika medical center between january 1, 2015 and march 31, 2017.The procedure of ercp was performed using an endoscopy (olympus; gf-uct260, tjf, jf, sif, pcf).It was not found what the model number of the endoscopy the surgeon used.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.However, omsc assumed that 3 serious infections might be associated with the duodenovideoscope.Therefore, omsc will submit 3 medical device reports (mdr) for 3 serious infections of the duodenovideoscope.This report is 2 of 3 reports for 3 serious infections of the duodenovideoscope.
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