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	03/09/2022
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.Per an intuitive surgical, inc.(isi) senior failure analysis engineer, a system log review cannot be performed because the system logs are not available at the time of this report.No video/images were provided by the customer for review.This complaint is being reported due to the following conclusion: after undergoing an ion endoluminal lung biopsy procedure, the patient allegedly developed a delayed pneumothorax.The patient was initially discharged after the procedure with no complications.The next day, the patient presented to the hospital with chest pain and shortness of breath.An x-ray was performed confirming a moderate sized pneumothorax.A chest tube was placed to resolve the pneumothorax and the patient was hospitalized for two days.
Event or Problem Description
It was reported that one day after an ion endoluminal lung biopsy procedure, the patient allegedly developed a delayed pneumothorax.The patient was initially discharged after the procedure with no complications.The next day, the patient presented to the hospital with chest pain and shortness of breath.An x-ray was performed confirming a moderate sized pneumothorax.A chest tube was placed to resolve the pneumothorax and the patient was hospitalized for two days.Reportedly, the patient has been discharged and is doing well.Per the physician, the size of the lesion that was biopsied was 1.5 cm.The lesion was in the right middle lobe, 2 cm from the pleura.There was no malfunction of the ion system, instruments, or accessories reported.The physician stated the patient was high risk for a pneumothorax due to a history of chronic obstructive pulmonary disease (copd).The physician believes that the ion products did not cause or contribute to the pneumothorax.

• 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: 13995425
• Report Number: 2955842-2022-10890
• Device Sequence Number: 20135425
• Product Code: EOQ
• UDI-Device Identifier: 00886874116241
• UDI-Public: (01)00886874116241
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/09/2022

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: 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: 03/09/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• 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: Unknown