Health Canada — Medical Devices · Canada · 2021-02-19 · Type II
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Reported risk: Olympus Medical Systems Corp. has identified an increase in the number of complaints from customers reporting that mucosal tissue was found within the single-use distal cover, MAJ-2315, after withdrawing the TJF-Q190V duodenoscope from the patient. In the reported complaints, the user facilities have reported mucosal injuries in the esophagus, stomach, and duodenum. Although most of the injuries reported did not necessitate additional treatment, two cases did require medical intervention: Proton Pump Inhibitor medication in one case and endoscopic therapy (such as clipping) in the another case. Olympus is thoroughly investigating the root cause or causes of these reported events. However, in the interest of transparency and to support the continued safe use of these devices, Olympus will send a letter to remind customers to follow the Instruction for Use and, where appropriate, to consider and follow information and recommendations supplied in the letter that may reduce the potential occurrence of similar incidents.
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