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

Model Number 380677-21

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

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

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was not confirmed based on the field evaluation.The fse was unable to duplicate errors 23016, 25553, and 25522.The fse replaced the right master tool manipulator (mtmr) (380451-06) and remote arm controller (rac) 2 (655040-11) as a precaution.The system was tested and verified as ready for use.The master tool manipulator (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).Intuitive surgical, inc.(isi) received the remote arm controller (rac) involved with this complaint and completed the device evaluation.Failure analysis investigation could not replicate the reported complaint.The remote arm controller (rac) was installed and tested in the test system and ran 10 minutes of sine cycle, 10 power cycles, and sat idle for one hour with no trouble found.Intuitive surgical, inc.(isi) received the right master tool manipulator (mtm); however, failure analysis remains in progress.A follow-up mdr will be submitted once fa has completed investigation of the component.As of 07/21/2020, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.This complaint is being reported due to the davinci system malfunction rendering the davinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if the reported malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted mitral valve repair surgical procedure, the customer experienced recoverable faults.The technical service engineer (tse) viewed the system logs and found errors 23016, 25553, and 25522 pointing to the right master tool manipulator (mtm) of surgeon side console (ssc) serial# (b)(4).The customer noted that prior to calling into technical support they had power cycled the system and the fault returned.The tse asked the customer to follow prompts to disable the right manipulator.Once the manipulator was disabled, the fault cleared and the surgeon was able to use the second ssc.The surgeon continued with the case on the second ssc.The procedure was completing as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the assistant or manager was unable to provide any patient demographics or further details.No additional information was obtained.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: g4, g7, h2, h3, h6, h10, and h11.67 - intuitive surgical, inc.(isi) completed the device evaluation on the master tool manipulator (mtm) involved with this complaint.Failure analysis investigation could not replicate nor confirm the reported complaint.A visual inspection was performed on the mtm.The mtm arm was then installed on to the test system.Since cycle and a test drive were performed without any issues.Tests performed via matlab passed.Failure analysis noted there was no trouble found on the mtm.Based on the new information obtained, there is no change in the reportability.This remains a reportable event.

• 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: 10323963
• MDR Text Key: 241925626
• Report Number: 2955842-2020-10683
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-21
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES