Medivators—ENDO SMARTCAP Tubing: Manufacturing Anomaly May Cause Various Problems during Procedures

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In an October 8, 2019, Urgent Medical Device Recall Notification letter submitted by ECRI Institute member hospitals, Medivators states that a manufacturing anomaly in the above tubes may present itself during endoscopic procedures, potentially causing inadequate insufflation, presence of air bubbles inside the tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. Medivators also states that it has received 25 reports of this problem occurring; however, it has received no reports of patient harm related to this problem. The manufacturer has not confirmed the...