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

Model Number 380677-03

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

Isi fse was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The fse replaced the mtml to resolve the issue.The system was tested and 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 his right (mtmr).Isi has received the mtml, however, failure analysis has not yet begun.Site history review: as of (b)(6) 2020, a review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image/video review: no investigation required as no image or video clip for the reported event was submitted for review.This complaint is being reported because system unavailability after start of a surgical procedure (first port incision) contributed to the procedure being converted.Although there was no patient harm reported, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that prior to the start of a da vinci-assisted surgical procedure, the customer observed re-occurring error 1 pointing to left master tool manipulator.There was no reported injury.Intuitive surgical, inc.(isi) obtained the following information about the complaint: the patient was administered anesthesia.The system was docked but surgery did not commence.The customer thought the issue was with a universal side manipulator for which they were going to proceed with 3 arms.However, it was ascertained the issue was the master tool manipulator at which point they paused.Technical support advised that it was error 1.Field service engineer advised the customer to undock and do a hard reset.However, the error could not be cleared.The procedure was converted to laparoscopy.

Manufacturer Narrative

4307 - intuitive surgical, inc.(isi) received the left master tool manipulator (mtml) involved with this complaint and completed the device evaluation.Failure analysis investigation reproduced the reported failure during calibration.Based on the additional information received, this event remains reportable.

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: 10210497
• MDR Text Key: 240449721
• Report Number: 2955842-2020-10603
• 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
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-03
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES