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1 record match for Intuitive Surgical, Inc.
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Not graded by the source2011-01-01FDA MAUDE2955842-2022-12290da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #1 INVOLVED A 48-YEAR OLD FEMALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY).¿IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE.¿ FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #1 (AND CASE #2) "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO CONVERSIONS IN STAPLING THE FISSURE OF THE LEFT UPPER LOBE. BOTH CONVERSIONS WERE CAUSED BY FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. THIS IS PARTLY ATTRIBUTABLE TO THE SPECIFIC CHARACTERISTICS OF THE 30 DEGREE ANGLED SCOPE: IT IS DIFFICULT TO OBSERVE LATERALLY U
cause not established2955842-2022-12290Intuitive Surgical, Inc.Read the record ↗