Olympus—Cystoscopy Bridges and Working Inserts: Adhesive Fragments May Detach
August 30, 2017 | Strategic Insights for Health System
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In an August 18, 2017, Urgent Medical Device Removal and Corrective Action letter submitted by an ECRI Institute member hospital, Olympus states that it has received reports of incidents in which fragments of adhesive detached from inside the working channel of the above bridges. Olympus also states that it has received reports of cracking, chipping, missing pieces, and delamination of the adhesive. If adhesive detaches during the intended use of the above bridges or working inserts (e.g., when inserting an instrument through the working channel), a fragment of adhesive may fall inside the patient's bladder or urethra, necessitating retrieval. Although they are typically flushed out with irrigation fluid or passed naturally, the retrieval of large fragments of adhesive could prolong the procedure or require additional surgical treatment. Olympus further states that it has received no...