Cook—AcuSnare Polypectomy Snares: Snare Loop May Not Completely Retract and/or May Be Misshapen
January 9, 2019 | Risk Management News
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In a January 4, 2019, Urgent Medical Device Recall letter submitted by ECRI Institute member hospitals, Cook states that the above snares may not fully retract or the snare loop may become misshapen. Cook also states that it has received 35 reports of this problem occurring and leading to perforation. This problem may also lead to an impacted snare, necessitating an attempt to perform polypectomy with an additional snare or retrieval by surgery. Cook further states that it has received five reports of serious injuries related to this problem. The manufacturer has not confirmed the...