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	Pneumothorax (2012)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
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 follow-up mdr will be submitted if additional information is received.As of (b)(6) 2022, a review of the site's system logs for the reported procedure date was conducted by an intuitive surgical, inc.(isi) failure analysis engineer (fae).Per the fae, 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.No video or images were provided by the customer for review.This complaint is being reported due to the following conclusion: after completion of an ion endoluminal lung biopsy procedure, a patient developed a pneumothorax.A chest tube was placed to resolve the pneumothorax.The patient was discharged home.The cause of the complication is unknown.
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 admission to the hospital for observation.The pneumothorax was identified via a post-procedure x-ray.Per the physician, the ion procedure did not cause the pneumothorax, but it occurred because the biopsy was a high-risk procedure and a pneumothorax is a known complication of the biopsy procedure.The initial size of the pneumothorax was 5-10% but increased in size, prompting the chest tube placement.The size of the lesion was 2.3 cm and the lesion was located in the left upper lobe, lingula on the fissure.The distance of the lesion to the pleura was 1.4 cm.The patient was hospitalized for a "short stay" and was doing well.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.

• 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: 15899146
• Report Number: 2955842-2022-15694
• Device Sequence Number: 17467482
• Product Code: EOQ
• UDI-Device Identifier: 00886874116272
• UDI-Public: (01)00886874116272
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 11/03/2022

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: 380748-44
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White