MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; SYSTEM CART

Model Number 380748-60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pneumothorax (2012)

Event Date 04/06/2023

Event Type  Injury  

Event Description

It was reported that after an ion endoluminal lung biopsy procedure, the patient developed a pneumothorax that developed in a delayed fashion after the procedure.The physician reported that he did not see any evidence of a pneumothorax on fluoroscopy during the procedure.The patient had three nodules - two were on the left and one on the right.The two nodules on the left were completed first and then the third nodule on the right side was completed - this is where the pneumothorax later occurred.The 3 lesions ranged in size from 1-2cm.The middle lobe lesion on the right side with the issue abutted the pleura.The physician believed the pneumothorax occurred because the nodule was in the middle lobe and sandwiched right between the lateral pleural and the fissural pleura.The physician did not think there was an issue with the biopsy using needles, but rather when doing the forceps biopsy he suspected he probably caused disruption near a pleural border and this was most likely what led to the air leak.Biopsy findings were benign, granulomatous, some atypical cells seen in right middle lobe nodule but ultimately these did not appear malignant.Initially, a repeat chest x-ray reveled a small pneumothorax that was subclinical and stable and the patient was only kept for overnight observation as it was evening and the patient lives far away.However, around 3 a.M., the patient experienced a coughing attack and then subsequently developed more symptoms of the pneumothorax.On another repeat cxr, the pneumothorax was large.After the coughing episode, the patient developed discomfort on the right side.It was suspected that the patient's cough exacerbated the sealed leak; therefore, a 14 french pigtail catheter was placed and the patient stayed in the hospital one more day until the pigtail was removed, and was discharged home on post-procedure day 2.The physician believed a pneumothorax could have potentially occurred via another biopsy modality and that it definitely would have been more likely to happen without the navigational information, but still possible even with navigation information.

Manufacturer Narrative

Based on the information provided, the root cause of the pneumothorax cannot be determined.The physician reported that the anatomical position of the right lung lesion/forceps biopsy site probably caused disruption near a pleural border and this was most likely what led to the air leak.There were no reported ion system issues for the right side lesion biopsy.A system log review cannot be performed because the system logs are not available.This complaint is being reported due to the following conclusion: after an ion endoluminal lung biopsy procedure, a patient developed a pneumothorax.A pigtail catheter was placed to resolve the pneumothorax.The procedure was completed and the patient was discharged home.

• Brand Name: ION
• Type of Device: SYSTEM CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16856114
• MDR Text Key: 314415334
• Report Number: 2955842-2023-12329
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• UDI-Public: (01)00886874116234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380748-60
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 60 YR
• Patient Sex: Male