Analysis of the MAUDE database reveals that the single operator cholangioscopy (SOC) system, specifically the SpyGlass DS and DS II devices, carries additional risks compared to standard endoscopic retrograde cholangiopancreatography. The study identifies 2,331 device problems reported between January 2016 and August 2023, with optical issues being the most prevalent. Patient-related events were found in 3.5% of reports, including bleeding, perforation, infection, fever, or sepsis, and pancreatitis. These findings offer important insights into the potential problems associated with SpyGlass SOC.
Journal Article by Chandan S, Ramai D (…) Kochhar GS et 3 al. in Gastrointest Endosc
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