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 may 13, 2021, olympus medical systems corp.(omsc) received the literature " ws13-9: esd strategy for tem residual recurrence caused anal canal proliferation-including intractable cases after fistula formation ".The purpose of the literature was to assess a useful strategy and the safety in endoscopic submucosal dissection (esd) for residual recurrence after transanal endoscopic microsurgery (tem) in the anal canal.The esd was performed using a knife (olympus; dual knife).Of the 263 cases of colon esd performed at kagawa university from january 2018 to september 2020, 3 cases of tem residual recurrence involving the anal canal were included.In the literature, two intraoperative perforations were reported.One patient with perforation had also postoperative bleeding.It was not found what severe and treatment of the perforation was.The other occurred after tem.This was a challenging case requiring deep incision due to a history of perforation during tem operation, abscess, and formation of aneurysm, and a part of the recurrent lesion was invaginated into a closed occlusion.However, the full-thickness excision was partially performed, but it was conservatively relieved by closing the clip and filling the pga sheet.The postoperative pathology was adenoma in all three patients.In all cases, there was strong fibrosis in the underlying layer that was difficult to identify, and dissection of the virtual muscle line was necessary.Based on the available information, a direct relationship between the olympus product and these complications could not be determined.However, perforation might be serious injury, and dual knife might be used when perforation occurred.This is the report regarding the patient with perforation and postoperative bleeding.
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