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

Model Number 380620-40

Device Problem Visual Prompts will not Clear (2281)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Bleeding (1888); Respiratory Arrest (4461)

Event Date 03/26/2022

Event Type  malfunction  

Event Description

During a da vinci-assisted hepatectomy procedure, prior to docking the patient side cart (psc) , arm 4 failed with error 23072.The system was re-started on hard cycle mode but the error persisted and arm 4 was disabled.The procedure was continued as a 3-arm system.Follow up was performed with the surgeon additional information was obtained.When the error occurred, the patient had ports inserted already.The disabling of the arm did not have an impact on the procedure or affect the accessibility of the posterior aspect of the liver.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.System log review verified error 23072 occurred.The reported issue was replicated as arm 4 failed with three restarts.The axes controller setup joint (acj) was replaced to resolve the issue.The system was tested and verified as ready for use.The product has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.The logs were reviewed by an intuitive surgical, inc.(isi) technical support engineer (tse) and the following findings were obtained: there were no procedures performed with the system since the reported issue.Error 23072 occurred on armnet 4 prior to start of procedure and site disabled universal surgical manipulator (usm) 4 prior to start of the procedure.A fso was created for the fse to troubleshoot and resolve the 23072 faults as well as perform system verification and test drive system to confirm system functionality.An image sent by the customer was reviewed by the clinical development engineering (cde) and the following information was received: the image shows excised liver tissue.Refer to the report under patient identifier (b)(6) for additional information related to the patient.This complaint is reportable due to the following conclusion: during a da vinci-assisted hepatectomy procedure, prior to docking the patient side cart (psc) , arm 4 failed with error 23072.The system was re-started on hard cycle mode but the error persisted and arm 4 was disabled.The procedure continued as a 3-arm system.A usm was disabled after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.Although the disabling of the arm did not impact the procedure, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after the start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.

Manufacturer Narrative

Additional information can be found in the following sections: d9, g3, g6, h2, h3, h4, annex b, annex c, annex d and h10.On 27-apr-2022, intuitive surgical, inc.(isi) received the following additional information from failure analysis: the unit was returned for failure analysis, but the reported failure could not be replicated/confirmed.The axes controller setup joint (acj) printed circuit assembly (pca) board was installed onto a test system and recalibrated without any problem.The board ran through 10 power cycles and sat idle for one hour, but the error was not replicated.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI X
• 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: 14228395
• MDR Text Key: 299296213
• Report Number: 2955842-2022-11270
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K171294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380620-40
• Device Catalogue Number: 380620
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic
• Patient Race: White