MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-17

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse replaced the master tool manipulator (mtm) due to errors 23008, 23013 and 23025.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the mtm involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed/replicated the reported complaint.The unit failed with error code 23013 during calibration via matlab.The axis 6 motor will be replaced as a fix.The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console.One mtm is assigned to the surgeon's left hand (mtml) and one to the right (mtmr).Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.System log review: the intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and noted errors 23008, 23013, and 23025 pointing to the master tool manipulator right (mtmr) axis 6 gimbal.Image/video review: no image or video clip for the reported event was submitted for review.This complaint is reportable due to the following: it was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the customer encountered repeated recoverable errors.Intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and noted errors 23008, 23013, and 23025 pointing to the master tool manipulator right (mtmr) axis 6 gimbal.The customer rebooted the system with no resolution to the issue.The surgeon elected to use another surgeon side console (ssc) to continue with the procedure.Isi followed up with the initial reporter and confirmed that the procedure was completed robotically with no injury to the patient.Although there was no patient injury reported, system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the customer encountered repeated recoverable errors.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and noted errors 23008, 23013, and 23025 pointing to the master tool manipulator right (mtmr) axis 6 gimbal.The customer rebooted the system, but the issue was not resolved.The surgeon elected to use another surgeon side console (ssc) to continue with the procedure.Isi followed up with the initial reporter and confirmed that the procedure was completed robotically with no injury to the patient.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 10955672
• MDR Text Key: 248142163
• Report Number: 2955842-2020-11308
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• 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: health professional,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-17
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• 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
• Patient Sequence Number: 1