MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-41

Device Problem Insufficient Information (3190)

Patient Problem Great Vessel Perforation (2152)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy procedure, an inadvertent jerking movement injured the pulmonary artery (pa).The surgeon attempted to control the bleeding with the cadiere forceps and ¿cigar¿ (rolled gauze) tamponade, but the procedure was converted to open via thoracotomy.Post-operatively, the patient remained intubated until the next day.There were no reported concerns of a da vinci system malfunction.The proctoring physician stated that the surgeon jerked their hand suddenly, which caused the damage to the pa, and that it was not caused by a da vinci product.

Manufacturer Narrative

No product has been returned to intuitive surgical, inc.(isi) for evaluation.There were no reported concerns of a da vinci system malfunction.A system log review did not reveal any system errors that would have caused or contributed to the reported event.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 18766257
• MDR Text Key: 336058139
• Report Number: 2955842-2024-11665
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Model Number: 380652-41
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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: DA VINCI INSTRUMENTS AND ACCESSORIES.