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

Model Number 380748-43

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pneumothorax (2012)

Event Date 12/01/2021

Event Type  Injury  

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, a system log review cannot be performed because the system logs are not available at the time of this report.A review of the site's complaint history revealed no additional complaints related to this event.No video/images were provided by the customer for review.This complaint is being reported due to the following conclusion: during an ion endoluminal lung biopsy procedure, the patient allegedly developed a pneumothorax.Although the patient remained asymptomatic, a chest tube was placed.The patent recovered with sequelae and was discharged after six days of hospitalization.

Event Description

It was reported that during an ion endoluminal lung biopsy procedure, the patient allegedly developed a pneumothorax.Per the physician, the pneumothorax occurred during transbronchial biopsies using biopsy forceps.The pneumothorax was identified intra-procedurally via fluoroscopy.The initial size of the pneumothorax was moderate and continued to increase in size.Although the patient remained asymptomatic, a chest tube was placed.The patent recovered with sequelae and was discharged after six days of hospitalization.The physician stated that there was no malfunction of the ion system, instruments, or accessories observed.

• 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: 13596830
• MDR Text Key: 290281845
• Report Number: 2955842-2022-10355
• Device Sequence Number: 1
• Product Code: EOQ
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White