MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CONTROLLER

Model Number	380707-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/27/2022
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.Per the physician, there was no malfunction of ion products and the device did not cause the pneumothorax.The procedure was completed.The physician stated the pneumothorax could have occurred with another modality.The biopsied lesion was 2 cm and located in the left upper lobe touching the pleura.The pneumothorax occurred post procedurally and the patient was asymptomatic.The pneumothorax was identified via chest x-ray and was moderate in size.An x-ray is available for isi review, but has not yet been received.A chest tube was placed to resolve the pneumothorax.No additional treatments were provided.The patient was hospitalized for 2 days and then discharged home in stable condition.
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.Per an isi senior failure analysis engineer, as of on (b)(6) 2022, a system log review was conducted and an investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.As of on (b)(6) 2022, a review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No video/images were provided by the customer for review.This complaint is being reported due to the following conclusion: after an ion endoluminal lung biopsy procedure, a patient developed a pneumothorax.A chest tube was placed to resolve the pneumothorax.The procedure was completed and the patient was discharged home.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is not applicable because the product is not implantable.Field is blank because it is unknown if the initial reporter submitted a report to the fda.Fields are not applicable.

• Brand Name: ION
• Common Device Name: CONTROLLER
• 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: 15113538
• Report Number: 2955842-2022-13175
• Device Sequence Number: 5874683
• Product Code: EOQ
• UDI-Device Identifier: 00886874116241
• UDI-Public: (01)00886874116241
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

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: 380707-33
• Device Catalogue Number: N/A
• 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: 06/27/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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
• Patient Sex: Male
• Patient Race: Native Hawaiian Or Other Pacific Islander