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1 record match for Intuitive Surgical, Inc.
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Not graded by the source2026-02-17FDA MAUDE2955842-2026-16404Ion Endoluminal System
Ion Endoluminal System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING PLACEMENT OF A CHEST TUBE AND HOSPITALIZATION. THE TARGETED LESION WAS A LEFT UPPER LOBE INFERIOR NODULE ABUTTING THE MOST INFERIOR PART OF THE LINGULA BEHIND THE HEART. PER THE PHYSICIAN, THERE WERE SUBOPTIMAL ANGLES AND THE DEPTH PERCEPTION WAS NOT GOOD. FINE NEEDLE ASPIRATIONS (FNA) PASSES AND FORCEPS WERE USED. THE PHYSICIAN REPORTED THAT THEY INSERTED THE FORCEPS FURTHER THAN INTENDED AND LIKELY CAUSED THE PNEUMOTHORAX. A LARGE PNEUMOTHORAX WAS IDENTIFIED DURING THE ION PROCEDURE; THEREFORE, A 14 FRENCH CHEST TUBE WAS PLACED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS HOSPITALIZED 4 DAYS THEN DISCHARGED HOME IN STABLE CONDITION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE DIAGNOSIS WAS MAC-NTM (MYCOBACTERIUM AVIUM COMPLEX NONTUBERCULOUS MYCOBACTERIA).
cause not established2955842-2026-16404Intuitive Surgical, Inc.Read the record ↗