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

Model Number 380677-04

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to conduct further investigation.The reported complaint was reproduced during field evaluation and confirmed through review of the system logs identifying the occurrence of recoverable error code 23013 at the right mtm axis 7 on sc2.The fse replaced the right mtm gimbal to resolve the issue.After replacement of this part, the system was further tested, operated without exhibiting any error, and was verified as ready for use.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).The replaced mtm gimbal has been returned to isi; however, evaluation/investigation has not been completed.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted when evaluation is completed and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.System log investigation: a review was performed using da vinci system (b)(4) confirming usage of the system for a procedure on the reported event date of (b)(6) 2020.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system's mtm on the sc2 unavailable for use after the start of a surgical procedure.System unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted or aborted.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted prostatectomy procedure using a dual surgeon console (sc) setup, the vision side cart (vsc) touchscreen displayed multiple instances of recoverable error code 23013.The customer received phone assistance from the technical support engineer (tse).A review of the site's system logs confirmed the occurrence of recoverable error code 23013 which pointed to the right master tool manipulator (mtm) axis 7 on the 2nd surgeon console (sc2).Troubleshooting was attempted by clearing the error fault on the vsc touchscreen; however, the issue remained persistent.The user disabled the right mtm on the sc2 to continue the procedure.No other issue was reported and there was no impact or patient consequence reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the system in dual sc setup was inspected prior to use and no issue was found.The issue was observed after surgeon control was switched from sc1 to sc2.With advice from the tse, the right mtm on sc2 was disabled.The procedure was completed using a dual sc setup with one mtm disabled.

Manufacturer Narrative

H6 result code: 120 - electrical problem.Additional information can be found in the following fields: g4, g7, h2, h3, h6, and h10.4307 intuitive surgical, inc.(isi) received the replaced right master tool manipulator (mtm) arm involved with this complaint and completed the device evaluation.During failure analysis, the mtm was installed into a reference/in-house system.The test system failed and displayed recoverable error code 23013 after subjecting the system to a sine cycle.The investigation confirms a defective axis 7 motor on the mtm arm.Based on the additional information, there is no change in the reportablity decision; this complaint remains reportable.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Refer to the following field for corrected information: d4 (model number) refer to the following fields for updated information: g3, g6, h2, and h10.This correction is being sent to update the product model number.

Event Description

Refer to h10/h11 for follow-up information.

• 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
• MDR Report Key: 10396593
• MDR Text Key: 204729837
• Report Number: 2955842-2020-10737
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.