Olympus—Model URF-V2 and Model URF-V2R Uretero-Reno Videoscopes: Insertion Tube Bending Section May Break during Procedure
January 4, 2017 | Risk Management News
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In a December 22, 2016, Urgent Medical Device Safety Notice letter submitted by an ECRI Institute member hospital, Olympus states that it has received reports related to breakage of the tube bending section on the above endoscopes during surgical procedures. Olympus also states that some of the reported incidents were associated with tissue trauma, including one case of perforation, and two cases of insertion tubes that were stuck inside the patient and had to be surgically removed. The manufacturer has not confirmed the...