MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-44

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

The upd has been returned to isi for analysis, but he testing has not yet been completed as of the date of this report.This 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.Although no patient harm occurred, if the reported malfunction were to recur it could cause or contribute to an adverse event.It was revealed that the customer had experienced this system error previously as well (during other surgical procedures), but technical support was not called for troubleshooting at the time of either of those events.A review of the system log was conducted and the following additional information was provided: the errors experienced by this system occurred about 20 minutes after the start of the procedure.A technical review was performed during the customer's call to technical support.The only troubleshooting that could be conducted over the phone was to try recovering from he fault by hard cycling the system.Since this was a recurring error on the patient side cart power distribution board error, onsite service by the fse was required to test the system.Follow-up was attempted, but the patient information was either unknown or unavailable.The expiration date is not applicable.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, non-recoverable fault 31221 occurred.Prior to calling technical support, the site had power cycled the system but the error returned.The system was not connected to the internet for the technical support engineer (tse) to view the logs.The tse asked the site to take a picture of the logs and email it for review.The tse had the site hard cycle and emergency power off the patient side cart (psc), and the system powered on without any error.The surgeon continued the surgery for a minute, but the errors returned.The tse had the caller read out the errors via pop up log and found error 31221 pointing to the patient cart controller (pcc) and the patient-side power distribution board (ppd).The tse had the site hard cycle and emergency power off again but leave the power off for 30 seconds before powering it back on.The system powered back on without error and the surgeon continued the procedure as planned.The site requested that their field service engineer (fse) call them to follow up.The fse later called the tse to acquire the log review and informed the tse that the site aborted the procedure due to the error returning after the phone call had ended.On 04/07/2020, intuitive surgical, inc.(isi) contacted the customer to obtain additional information about the complaint.The reporter was not present during the procedure; her knowledge on the procedure came from the or staff informing her of the events.None of the or staff who were present during this event were available to talk at the time.During the procedure, non-recoverable faults were occurring.The reporter did not know how far into the procedure the errors started happening.The or staff called technical support and performed troubleshooting.After completing troubleshooting the error returned.It is unknown how long after ending the call with technical support that the error returned.The surgeon elected to abort the procedure at this time due to the errors returning.It was reported that there was no patient injury.

Event Description

Refer to h10/h11 for additional information.

Manufacturer Narrative

67 - an isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was unable to reproduce the 31221 fault.The fse performed a test drive of the system using his own instruments and an endoscope from the site.The fse left the system on and manipulated the arms and utilized the erbe for one hour without any faults occurring.The fse replaced the universal power distributor (upd) as a precaution.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the parts involved with this complaint and completed the device evaluation.The board was installed on the pca test system and came up with no errors, and normal system operation.The system ran 10 power cycles with no errors, the board remained in the test system for 1 hour and at the end of the idle time, the upd failed with error 31221, highside switch fault.Failure analysis replicated the reported error.Based on the additional information obtained, this complaint remains a reportable event.If additional information becomes available, a follow-up mdr will be submitted.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10007675
• MDR Text Key: 222560479
• Report Number: 2955842-2020-10348
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Weight: 93