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

Model Number 380652-39

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 10/28/2021

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the root cause of the intra-operative complication cannot be determined or is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, there are no isi products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history does not show any additional complaints related to 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.Additionally, all reusable instruments used in the case were used in subsequent procedures with the exception of the curved bipolar dissectors and a site review shows no complaint filed against the instruments.The system logs were reviewed by isi advanced failure analysis (afa) engineering and the following information was obtained: all of the errors in the logs for that procedure are class 0 (system service advisory (no fault reaction)) and class 8 (engineering event informational (no fault reaction).There are no errors near the end of the procedure when the case needed to be converted.The synchroseal logs were reviewed by an isi advanced failure analysis engineer (fae) and the following findings were obtained: no errors were recorded during the use of the synchroseal instrument.The instrument was used for 7 transections, 3 coagulation activations, and 16 seals over approximately 15 minutes.Additionally, there are no relevant errors in the msc system logs.A review of the event was conducted by an isi medical officer and the following additional information was provided: the information presented in the description of events is not adequate to determine the potential root cause of the event and if any intuitive product caused or contributed to the event.Based on the information provided at this time, this complaint is reportable due to the following: during a da vinci-assisted pulmonary lobectomy procedure, there was an injury to the pulmonary artery which resulted with bleeding.As a result, the surgeon elected to convert the case to open surgery to try and control the bleeding.The patient subsequently expired on the table.Although there is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, the cause of the intra-operative complication 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.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported by a physician assistant that during a da vinci-assisted pulmonary lobectomy procedure, there was an unspecified injury to the pulmonary artery and the patient was bleeding.The procedure was converted to open and the patient died on the table.The physician assistant who reported the case did not assist in the procedure.Intuitive surgical, inc.(isi) followed up with the risk manager and obtained the following information: an injury occurred to the pulmonary artery towards the end of the case when the surgeon was "closing up." there was a massive amount of bleeding and as a result, the procedure was converted to open surgery.Attempts to control the bleed were unsuccessful.The patient died on the table.The risk manager said that there were no product issues, no unexpected movement of the system or instruments, and no issues with the visualization of the surgical field.There were also no anatomical factors or any pre-existing illness in the patient that contributed to the injury.She was unable to provide information as to the cause of bleeding, what medical intervention was done to try and stop the bleeding, what the surgeon/site thinks was the cause of injury/death, and the cause of death as written on the death certificate or autopsy report.There are no instruments available for return.She declined to provide any demographic information/relevant pre-existing medical illness or relevant investigation of the patient.Multiple attempts have been made to contact the surgeon and director of perioperative services to obtain additional information regarding the reported event.However, as of the date of this report, no new information has been received.

Manufacturer Narrative

On 10-dec-2021, intuitive surgical, inc.(isi) received the following additional information: an isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse did not find any issues with the system.The system was tested and verified as ready for use.A review of the system logs was also completed.There were no errors observed that would have led to any system issue causing or contributing to the injury/death.

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: 12972774
• MDR Text Key: 282030515
• Report Number: 2955842-2021-11705
• 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,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• 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: 380652-39
• Device Catalogue Number: N/A
• 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: 12/09/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• 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