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

Model Number	380748-43
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/21/2021
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 obtained.A review of the site's system logs for the reported procedure date was conducted by an isi failure analysis engineer.The 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/images were provided by the customer for review.This complaint is being reported due to the following conclusion: a patient underwent an ion endoluminal lung biopsy procedure and developed a pneumothorax.A chest tube was placed to resolve the pneumothorax and the patient required hospitalization for an unspecified duration.The cause of the complication is unknown.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.
Event or Problem Description
It was reported that the patient underwent an ion endoluminal lung biopsy procedure and developed a pneumothorax.A chest tube was placed to resolve the pneumothorax and the patient required hospitalization for an unspecified duration.The cause of the pneumothorax and the procedure outcome are unknown.Intuitive surgical inc.(isi) made several attempts to obtain additional information; however, there was no response received from the physician.
Additional Manufacturer Narrative
On 15-apr-2022, the following additional information regarding the event was received from the physician: the lesion biopsied during the procedure was in the right middle lobe (rml) and 14 mm in size.The lesion was approximately 7 mm from the pleura.The pneumothorax was identified during a routine chest x-ray in the recovery room.Although the pneumothorax was moderate in size (20-30%), the patient remained asymptomatic.The patient was admitted to the hospital for two days.The physician confirmed that there was no malfunction of an ion product and does not believe that an ion product caused or contributed to the pneumothorax.The procedure was completed.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 14131793
• Report Number: 2955842-2022-11089
• Device Sequence Number: 11331916
• Product Code: EOQ
• UDI-Device Identifier: 00886874116241
• UDI-Public: (01)00886874116241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/15/2022

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: 380748-43
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 04/16/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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: Female