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

Model Number 380748-60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pneumothorax (2012)

Event Date 12/28/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the root cause of the customer reported complication cannot be determined.The physician reported the lesion location was high risk for potential pneumothorax.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.A review of the site's system logs for the reported procedure date was conducted and the investigation revealed that no related system errors occurred during the procedure that would have likely caused or contributed to the reported complaint.This complaint is being reported due to the following conclusion: after an ion endoluminal lung biopsy procedure, a patient developed a pneumothorax requiring a chest tube and hospitalization.The procedure was completed and the patient was discharged home.

Event Description

It was reported that the patient underwent an ion endoluminal lung biopsy procedure and developed a pneumothorax requiring a chest tube and hospitalization.The lesion biopsied was 1.5cm and in the right upper lobe.Tools utilized included a 21g flexision needle with compatible forceps and cytology brush.Imaging modalities included c-arm fluoroscopy and radial ebus (endobronchial ultrasound).Per the physician, the patient was high risk for a pneumothorax because the lesion was a 1.5cm lesion that was right up against the pleura, lesion distance to pleura was 0mm.The physician believed the pneumothorax could have potentially occurred via another biopsy modality.The procedure was completed.The physician stated there was no ion system malfunction.The pneumothorax was identified post procedurally via chest x-ray right after the procedure finished.The patient was asymptomatic.The initial size of the pneumothorax was 3cm and did not increase over time because a 14 french chest tube was placed immediately.No other medical intervention was provided.The patient was hospitalized for 2 days then discharged home.The biopsy yielded a diagnosis of histoplasmosis.There is no allegation that a malfunction of an ion system, instrument, or accessory occurred.

• Brand Name: ION
• Type of Device: 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: 16676249
• MDR Text Key: 312643315
• Report Number: 2955842-2023-11745
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• UDI-Public: (01)00886874116234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380748-60
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ION ENDOLUMINAL SYSTEM
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White