MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number 380610-12

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591)

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

Event Date 12/02/2019

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 remote arm controller (rac) due to the communication errors on the master tool manipulator right (mtmr).The system was tested and verified as ready for use.The product has been received, but failure analysis has not yet been completed.Based on the information provided at this time, this complaint is being reported because the system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer encountered error 16 on master tool manipulator right (mtmr) while docking the system.The customer performed the emergency power off (epo) on the system, power cycled the system/the circuit breaker, and switched out the blue fiber cable; however, the reported issue remained.In addition, the customer encountered error 281 and 31030.The customer aborted the procedure with no patient injury.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

The following fields were updated with additional information: (b)(4) - an isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse replaced the remote arm controller (rac) due to communication errors on the right master tool manipulator (mtm).The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the rac involved with this complaint and completed the device evaluation.Failure analysis investigation could not replicate the reported complaint.The unit was tested in the test system and no issues were noted.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9477807
• MDR Text Key: 193910635
• Report Number: 2955842-2019-10969
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES