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

Model Number	380748-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the current information provided, the cause of the operative complication cannot be determined.A follow-up mdr will be submitted if additional information is obtained.System log review: per an isi advanced failure engineer, a system log review cannot be performed because the system logs are not available at this time.No image or video clips for the reported event were submitted by the customer for review.This event is being reported due to the following conclusion: after completion of an ion endoluminal lung biopsy procedure, the patient developed a pneumothorax.A chest tube was placed to resolve the pneumothorax.
Event or Problem Description
It was reported that after an ion endoluminal lung biopsy procedure, the patient developed a pneumothorax which required chest tube placement.The physician believed the device did not cause or contribute to the event.The patient was reported to be stable.There was no allegation of device malfunction associated with the event.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information; however, no further details have been received as of the date of this report.

• 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: 16429334
• Report Number: 2955842-2023-10837
• Device Sequence Number: 5411134
• Product Code: EOQ
• UDI-Device Identifier: 00886874116272
• UDI-Public: (01)00886874116272
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/30/2023

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: 380748-60
• Device Catalogue Number: 380748
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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 Sex: Unknown