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

Model Number 380677-13

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse could not reproduce the original complaint.The fse replaced the right mtm out of caution.The system was tested and verified as ready for use.Isi has not received the right mtm involved with this complaint.Therefore, the root cause of the alleged customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the unit is returned (post failure analysis evaluation) or if additional information is received.A site history review on (b)(6) 2020 was performed and there were no other complaints related to the event identified.A system log review was performed and confirmed error 23 occurred.No images or videos of the event were provided for review.No additional technical review was required based on the complaint.This complaint is assessed as a reportable event due to the following conclusion: the right mtm continued to turn to the right by itself despite troubleshooting that was performed.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 his right (mtmr).The mtm not working as intended would prevent the surgeon from controlling the system.The patient ports were already inserted at this point and the unavailability of the system led to the surgeon converting the surgery to a laparoscopic procedure.While there was no harm or injury to the patient, the reported failure mode could potentially cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted ventral hernia repair, the customer reported that the right master tool manipulator (mtm) turned by itself.As soon as instruments and the endoscope were installed, the right mtm turned to the right and the surgeon was not able to adjust it.The customer contacted a technical service engineer (tse) who viewed the system logs and noted error 23.The tse recommended the customer power down the system, perform a hard power cycle on the surgeon side cart (ssc), and reseat the blue fiber cable on both ends, but the issue remained.Customer had system set up for a 3-arm case (arms 2,3, and 4 with the endoscope installed into arm 4).The tse advised the customer to install the endoscope into arm 3.The customer swapped the endoscope, but the issue remained.The customer also tried using arms 1, 2, and 3 for the endoscope, power cycled the system multiple times and performed guided setup but as soon as the instruments were installed, the right mtm automatically rotated to the right (right mtm mirrored left mtm in position).The tse then had the surgeon verify and then adjust hand control assignments within the settings on the ssc, but the issue remained.The clinical sales representative (csr) confirmed that the system setup looked good.The right mtm also dropped towards the ground when the system was powered down and during the homing process and did not seem to match what the left mtm was doing.The surgeon decided to convert the procedure to a laparoscopy procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the reporter and obtained the following information: the system had preventative maintenance performed.The field service engineer (fse) went to the site to test the system and noted that when the endoscope was inserted in either universal surgical manipulator (usm) 1 or 4, the mtms would point towards the camera.The staff confirmed that, during the incident, both mtms pointed towards the right even when the endoscope was inserted on usm 3, with instruments on both sides.The surgery was completed successfully laparoscopically and there was no injury/harm.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

4307 - intuitive surgical, inc.(isi) received the master tool manipulator (mtm) involved with this complaint and completed the device evaluation.The failure reported by the customer was reproduced.The embedded serializer in master base (esmb) printed circuit assembly (pca) and the main wire harness were replaced.Additional findings not reported by the customer: due to the gimbal handle being replaced, the embedded serializer for master handle (esmh) pca was also replaced to accommodate the repair.During evaluation, the opto button pads were found to be worn out and replaced.Physical damage to the gimbal grip levers and gimbal handle was observed during evaluation.Both grip levers and gimbal handle were replaced.The inner and outer grip spring within the gimbal handle was found to be broken and were replaced.The gimbal pads were worn out and replaced.This complaint remains a reportable event due to the following conclusion: the right mtm continued to turn to the right by itself despite exhausting troubleshooting.The ports were already inserted at this point and the unavailability of the system led to the surgeon converting the surgery to a laparoscopic procedure.

• 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: 10177007
• MDR Text Key: 233246459
• Report Number: 2955842-2020-10584
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-13
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES