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1 record match for Intuitive Surgical, Inc.
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Not graded by the source2012-01-01FDA MAUDE2955842-2022-12342da 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 #2 INVOLVED A 66-YEAR OLD FEMALE PATIENT WITH STAGE 1A 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 AORTA.¿ ¿IN CASE 2, THE AORTA WAS PARTIALLY STAPLED UPON DIVIDING THE INTERLOBAR FISSURE BETWEEN THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE AND THE APICAL SEGMENT OF THE LEFT LOWER LOBE, WHICH WAS REPAIRED BY END-TO-END ANASTOMOSIS UNDER BYPASSING WITH EXTRACORPOREAL MEMBRANOUS OXYGENATION. IN BOTH CASES CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #2 (AND CASE #1), "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO C
cause not established2955842-2022-12342Intuitive Surgical, Inc.Read the record ↗