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

Model Number 380652-42

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse found repeated 32100 errors pointed towards a voltage monitoring fault on axes controller platform (acp) 5.On 4/2/2020, the fse attempted to replicate the reported fault (32100 error) and encountered no errors.Then fse removed/replaced acp 5 and completed checks on all cable connections associated with the dual acp (acpd).Following replacement of acp5 the system was fully functional and no errors were present.The next day, on (b)(6) 2020, the customer encountered the same error 32100 during a training event.The fse planned to return, bringing a motor/brake assembly and acpd to perform further troubleshooting to address the issue.After the fse returned to the site for troubleshooting, the customer confirmed that no further errors occurred since the acpd 4 and acpd 5 were swapped.Following service, the system was checked and verified as ready for use.An rma has been issued to have the isi device (i.E.Acp) returned; however, isi has not received the rma to confirm/identify any reportable failure mode(s).A review of the site's system logs was performed by the tse during the initial troubleshooting with the customer.No image or video clip for the reported event was submitted for review.No other complaints for this event were reported by the customer.This complaint is being classified as a reportable event due to the following conclusion: system unavailability after start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopic.While there was no harm or injury to patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the patient information was either unknown or unavailable.The product is not implantable.

Event Description

It was reported during a da vinci-assisted cholecystectomy procedure the surgical staff encountered repeated 32100 errors.The system generated the error when the patient side cart (psc) boom was adjusted when docking to the patient.Prior to calling technical support, the customer tried to power cycle the system and the error persisted.The technical support engineer (tse) reviewed system logs and found the error (32100) was reported by the axes controller platform (acp) 5 brake current on output 1 (j10).The reporter found the system would generate the 32100 error when the surgical staff depressed the deploy for docking or enabled joysticks on the psc touchpad.Tse guided the customer through two hard power cycled of the psc, but there was no change in error.The reporter explained the surgeon elected to convert the procedure to laparoscopic.Intuitive surgical, inc.(isi) completed follow-up with the robotics coordinator and confirmed the surgeon completed the case via laparoscopic surgery with no reported patient injury.

Manufacturer Narrative

67 - intuitive surgical, inc.(isi) received the axes controller platform (acp) associated with this complaint and completed its investigation.Failure analysis (fa) could not replicate the reported error 32100.The acp was installed and tested on an in-house system and it started up with no issue.The unit passed in-house testing with no reported anomalies.Fa concluded there was no trouble found on the unit.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 9988224
• MDR Text Key: 193914378
• Report Number: 2955842-2020-10336
• 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: 03/30/2020

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: 380652-42
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES