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

Model Number 380677-16

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer visited the site to inspect the system and test against the reported issue.The left master tool manipulator was replaced to resolve it and the system was confirmed as ready for use.The master tool manipulator 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).Isi received the master tool manipulator involved with this complaint and completed the device evaluation.Failure analysis investigation was unable to reproduce the reported issue, but it was confirmed as having occurred via field error logs.Visual inspection was performed.The mtm was installed onto the system and powered up.A sine cycle and a test drive were performed without any issues.The mtm passed all the tests that were performed via matlab.No repairs are required to address the reported problem.No photo or video was provided for review.No other complaints related to this event were reported by the customer.The complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure which resulted in the procedure being converted to a laparoscopic procedure.Although no patient harm occurred, if the reported malfunction were to recur, it could cause or it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the system generated error 23031 pointing to the left master tool manipulator.An intuitive surgical, inc.(isi) technical support engineer viewed the logs and was able to confirm multiple 23031 entries pointing to a button sensor 1 on mtml.The tse guided the customer to perform emergency power off (epo) plus cycle the breakers; but, the issue persisted.The procedure was converted to laparoscopic procedure.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information; the customer confirmed that the system was inspected prior to use and no issue was observed.There were no issues with the port placements.It was noted that an instrument was being exchanged when the issue occurred and the surgeon was using the mtm.The customer did attempt to reseat the instrument and the drape.There was no harm or injury to the patient.

Manufacturer Narrative

Refer to the following fields for corrected information: d4 (model number, catalog number, lot number, serial number, and udi), h4 refer to the following fields for updated information: g3, g6, h2, and h10 this report is being submitted to provide corrected product information.

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: 10204233
• MDR Text Key: 240452162
• Report Number: 2955842-2020-10600
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-16
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES