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

Model Number	380718-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ion endoluminal lung biopsy procedure, the patient developed a pneumothorax requiring a chest tube and hospitalization.The patient's medical history includes copd, lung cancer, and current smoker.The biopsied lesion was 9 mm and in the right middle lobe.The distance to the pleura was 1cm.A pneumothorax was identified post-procedure via chest x-ray.The pneumothorax was 1.5cm in size and did not increase over time, and the patient was asymptomatic, but the physician opted to place a chest tube.No medication or oxygen was provided.The patient was hospitalized for two days and discharged home in stable condition.Per the physician, the ion system did not contribute to the pneumothorax, and a pneumothorax may have occurred with another biopsy modality.There is no allegation that an ion system, instrument, or accessory malfunction occurred.
Additional Manufacturer Narrative
Based on the information provided, the root cause of the customer reported complication cannot be determined.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.A system log review cannot be performed because the system logs are not available.A review of the brief case video provided by the customer confirms that an ion bronchoscopy with biopsy was performed.Standard tools were utilized including radial endobronchial ultrasound and fluoroscopy with nothing unusual noted.This complaint is being reported due to the following conclusion: after an ion endoluminal lung biopsy procedure, a patient developed a pneumothorax requiring a chest tube and hospitalization.The patient was discharged home in stable condition.

• Brand Name: ION
• Common Device Name: 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: 16812016
• Report Number: 2955842-2023-12190
• Device Sequence Number: 5682881
• Product Code: EOQ
• UDI-Device Identifier: 00886874116272
• UDI-Public: (01)00886874116272
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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: 380718-30
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White