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 07/17/2020

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 replaced the master tool manipulator (mtm) to resolve the reported problem.The system was tested and verified as ready for use.Isi received the mtm involved with this complaint and completed the device evaluation.Failure analysis investigation was able to reproduce the reported failure during calibration.Due to the gimbal handle being replaced, the embedded serializer for master handle (esmh) pca was also replaced to accommodate the repair.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.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 also observed during evaluation.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).A system log review was performed and confirmed that errors 100 and 31010 occurred.No images or videos of the event were provided for review.A review of the site's complaint history identified no events other than the mtm issue.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.The right mtm was not working as intended and it prevented the surgeon from controlling the system.The unavailability of the system led to the surgeon converting the surgery 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 master tool manipulator (mtm) was not working properly and the surgeon was unable to move the instrument.An intuitive surgical, inc.(isi) technical support engineer (tse) reviewed live logs and identified error 31010 pointing to a missing sterile adapter (sa).The tse had the customer to re-seat the drape and check sa/instruments for proper engagement with no resolution.The customer then tried another instrument on universal surgical manipulator 3 (usm3) ; but, the issue persisted.The customer noted that the clutch from the right mtm was not responding.The tse had the customer perform an emergency power off (epo) and cycle the breakers without success.The tse also asked the customer to exercise the right mtm twice; but, the surgeon did not want to troubleshoot anymore.The procedure was converted to a laparoscopic surgery.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was a "one-on-one surgery." the issue encountered occurred at the end of the procedure.There was no additional anesthesia administered to the patient.The patient was reported to be doing fine following completion of the surgery.

• 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
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10393414
• MDR Text Key: 238136705
• Report Number: 2955842-2020-10734
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• 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: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1