MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP PATIENT SIDE CART

Model Number 380601-34

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the facility to further troubleshoot the issue. The fse replaced the axis motor to correct the reported problem. The system was verified and ready for use. Isi received the axis motor involved with this complaint and completed the evaluation. Failure analysis was able to confirm and reproduce the original complaint. The unit failed iloop twang test on pftp and triggered 23038 error. Upon visual inspection, the pca hall sensor wire was found damaged which could cause 23038 error. Log review could not be performed since the axis motor unit does not get captured by the logs. No images or videos were shared for the event. Isi technical support performed a system log review and confirmed the customer reported errors. Based on the information provided, this event is being reported due to the following conclusion: system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted. Although no patient harm occurred, if the reported malfunctioned were to recur it could cause or contribute to an adverse event. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Implant is not applicable because the product is not implantable. Field is not applicable.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the system faulted with 23038 when the customer went to deploy for docking. The customer was able to recover, but then got 23087 and 23076 errors. They tried to move the gantry back to stow position and tried again to dock, but it faulted again. The customer tried a complete hard power cycle of all breakers and performed an emergency power off (epo) of the patient side cart (psc), but the issue persisted. The procedure was converted to an open surgical procedure. There was no reported injury to the patient. Intuitive surgical, inc. (isi) technical support noted that the customer was able to move the psc without any issues. The issue they were experiencing was the system column would not move up and down without any errors so they could not deploy the psc to prepare for docking. There is no way to manually move the gantry. Isi contacted the original reporter and obtained the following information: the customer performed five system shut downs and two hard power cycles attempting to rectify the issue, but there was no resolution. The reporter did not have any patient information. There was no injury to the patient.

• Brand Name: DA VINCI SP
• Type of Device: PATIENT SIDE CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11043230
• MDR Text Key: 250323989
• Report Number: 2955842-2020-11386
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 380601-34
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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