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

Model Number 380614-11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the post-operative complication is unknown.There was no report or allegation from the customer of a deficiency of the da vinci system, instrumentation, or accessories associated with the reported incident.Therefore, there are no products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.A follow up mdr will be submitted if additional information is received.A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No image or video clip for the reported event was submitted for review.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search showed no complaints filed against those instruments, including the reusable instruments that were used in subsequent procedures.Based on the information provided, this event is being reported due to the following conclusion: after undergoing a da vinci-assisted left lower lobe resection procedure, the patient experienced a cerebral infarction on the second post-operative day (pod).There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred; however, the cause of the cerebral infarction is unknown.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that after a da vinci-assisted left lower lobe resection procedure on (b)(6) 2021, the patient experienced a cerebral infarction on (b)(6) 2021.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following additional information: it was noted that the system, instruments, and accessories were inspected prior to use and nothing abnormal was found.There were no issues with any vessel ligation and the surgeon said there was no operational problems.The surgeon reportedly said, "there is no difference in the location of the ligature compared to video assisted thoracic surgery (vats).The operation time was 1.5 hours longer than vats but equal to the previous robotic assisted thoracic surgery (rats).The surgeon was asked if any malfunction occurred with any da vinci system, instrument, or accessory to which the surgeon said there ¿was no malfunction found.¿ the surgeon stated that the post-operative cerebral infarction was an expected complication for thoracoscopic surgery in the left lung.It was unknown if the cerebral infraction was ischemic or hemorrhagic and what, if any, medical intervention was required.The surgeon did not know if the patient was on any medication, if they had a history with blood disorder, or if there was any issues with recovery from anesthesia.As of (b)(6)2021, the patient was in the hospital and recovering.

• Brand Name: DAVINCI SI
• 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: 12976560
• MDR Text Key: 282052810
• Report Number: 2955842-2021-11711
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/12/2021

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: 380614-11
• Device Catalogue Number: 380614
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2013
• 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
• Patient Sex: Male
• Patient Race: Asian