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

Model Number 380652-56

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2023

Event Type  Death  

Manufacturer Narrative

The surgeon stated that there were no concerns or issues with da vinci products used during the procedure.A device history record (dhr) review was performed for the device(s) involved with this reported event and no related non-conformances were identified.A review of the da vinci system logs found no relevant error codes.The system has been used in multiple subsequent procedures, and a review of the system logs for the 5 subsequent procedures after the reported event also found no errors relevant to the reported event.A review of the system logs found that all multi-use instruments that were used in the procedure have been used in subsequent procedures (endoscope, atrial retractor short right, debakey forceps, monopolar curved scissors, cardiac probe grasper, long tip forceps, maryland bipolar forceps, large suturecut needle).The suction irrigator is a single use product; therefore, was not used again.A review of the site's complaint history shows no complaints have been reported for any of the instruments.A review of the event was performed by an intuitive surgical, inc.Medical safety officer (mso) who concluded that the patient in this report died following a mitral valve repair, and the events leading up to the death and the eventual cause of death are unknown.Based on the information provided in the summary of events, insufficient information is available to ascertain if any intuitive surgical products or instruments contributed to this event.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

Event Description

It was reported that after a da vinci-assisted mitral valve repair (mvr) surgical procedure, an unspecified complication occurred and the patient expired.The surgeon reported that the procedure was successfully completed robotically on (b)(6) 2023 and that it is routine protocol for all mvr patients to be admitted to the intensive care unit (icu) for recovery due to needing additional support post-surgery (e.G., ventilation).The surgeon reported that this patient was noted to require more support than normal in the icu; however, declined to provide details stating that the additional support was related to patient specific needs.The surgeon stated they had no concerns or issues with da vinci products used during the procedure.It was later learned that the patient subsequently expired on (b)(6) 2023.

Manufacturer Narrative

Section b5 additional and corrected information: a legal claim was received for this event.The additional information received corrects that "on (b)(6), 2023, [the surgeon] performed a mitral valve annuloplasty and septal shaving.The legal claim further states that ¿after completion [of the procedure] [the patient] was unable to be transitioned off conventional cardiopulmonary bypass and suffered severe systolic anterior motion (sam) and severely reduced right ventricular performance."after several repeated attempts to transition [the patient] off cardiopulmonary bypass; [the patient] was placed on veno-arterial extracorporeal membrane oxygenation (ecmo)." the legal complaint further states, "thereafter, repeat tees [transesophageal echocardiogram] in the icu revealed overall poor right-sided heart performance with tricuspid regurgitation¿thereafter, [the patient] developed hepatic and renal failure.Atrial fibrillation and ventricular arrhythmias.¿ the legal complaint also stated, ¿[the patient] died (b)(6) 2023, as a result of prolonged cardiogenic shock, organ malperfusion and worsening multi-system organ failure".Corrected evaluation due to receipt of the corrected procedure date: a device history record (dhr) review was performed for the device(s) involved with this reported event and no related non-conformances were identified.A review of the da vinci system logs found no relevant error codes.The system has been used in multiple subsequent procedures, and a review of the system logs for the 5 subsequent procedures after the reported event also found no errors relevant to the reported event.A review of the system logs found that all multi-use instruments that were used in the procedure have been used in subsequent procedures (endoscopes, potts scissors, monopolar curved scissors, atrial retractor short right, debakey forceps, maryland bipolar forceps, large suturecut needle).The suction irrigator is a single use product; therefore, was not used again.A review of the site's complaint history shows no complaints have been reported for any of the instruments.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18070384
• MDR Text Key: 327351533
• Report Number: 2955842-2023-19949
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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,Followup
• Report Date: 10/06/2023

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: 380652-56
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/04/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White