MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC Ion; System Cart

Model Number	380748-44
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ion transbronchial lung biopsy procedure, the patient experienced pulseless electrical activity (pea).Near the end of the case, as the team began extubation, the patient lost pulse, however, no resuscitation measures were required.The biopsy was obtained from the lower lobe, just above the diaphragm.During the procedure, it was noted that the airway looked really big on the spin, but no complication was apparent until the procedure had concluded.The patient was discharged home the same day and was doing well.Per the physician, there was no pea during bronchoscopy.It was reported that the procedure itself was performed without issue.There was no allegation that a malfunction of an ion system, instrument, or accessory occurred.Intuitive surgical, inc.(isi) attempted follow-up to obtain additional information; however, the physician did not recall a pea event.
Additional Manufacturer Narrative
A review of the event was conducted by an isi medical officer and the following additional information was provided: "following an ion biopsy procedure and during extubation, patient experienced pea arrest that resolved without resuscitative efforts.Patient was subsequently discharged in stable condition.Bronchoscopy and biopsy is a minimally invasive procedure with a low complication rate and rarely associated with fatal complications.In a multicenter prospective study of 20,986 bronchoscopies the total number of any complications was reported to be 227 (1.08%) with 4 total deaths (0.02%).A multicenter study reported 13 (2.2%) complications with no deaths associated with 581 cases.A prospective multicenter international study of 1,215 reported 1 associated death (0.08%).Another survey-based study of 103,978 bronchoscopies described 71 cases (0.068%) of associated cardiovascular events.A recent meta-analysis of navigational bronchoscopy in 10,381 patients reported an overall adverse event rate of 5.6% with 1 death.A case series of ion robotic assisted bronchoscopies published after the meta-analysis including 415 cases reported no deaths.There was no allegation of a malfunction of the ion system, instrument or accessories associated with the reported complication.The available data suggests that the ion system did not contribute to the adverse event but it is possible the adverse event was related to the procedure including anesthesia in a patient with underlying cardiovascular co-morbidities." facciolongo n, patelli m, gasparini s, et al.Incidence of complications in bronchoscopy.Multicentre prospective study of 20,986 bronchoscopies.Monaldi archives for chest disease.2009;71(1).Ost de, ernst a, lei x, et al.Diagnostic yield and complications of bronchoscopy for peripheral lung lesions.Results of the aquire registry.Am j respir crit care med.2016;193(1):68-77.Folch ee, pritchett ma, nead ma, et al.Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: one-year results of the prospective, multicenter navigate study.Journal of thoracic oncology.2019.Kops sep, heus p, korevaar da, et al.Diagnostic yield and safety of navigation bronchoscopy: a systematic review and meta-analysis.Lung cancer.2023.Brownlee ar, watson jjj, akhmerov a, et al.Robotic navigational bronchoscopy in a thoracic surgical practice: leveraging technology in the management of pulmonary nodules.Jtcvs.2023.

• Brand Name: Ion
• Common Device Name: System Cart
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; +1(408)523-2100
• MDR Report Key: 50793858
• Report Number: 2955842-2026-38664
• Device Sequence Number: 15813160
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• UDI-Public: (01)00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 380748-44
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Ion Endoluminal System
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Sex: Male