MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; SURGEON SIDE CONSOLE, RECONDITIONED

Model Number 380723-02

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/08/2020

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 remote arm controller (rac) circuit board on the surgeon side console (ssc) due to intermittent error code 25580.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the rac board involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed/replicated the reported complaint.The unit was installed into the test system and failed with error code 25580.The unit was disassembled and fluid contamination was found inside.Based on the information provided at this time, this complaint is being reported because during a da vinci-assisted surgical procedure, the customer could not use the system due to repeated error code 25580.The system unavailability after start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that prior to starting a da vinci-assisted surgical procedure, the customer encountered repeated error codes 25580.Intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and confirmed error codes 25580 pointing to the remote arm controller (rac) circuit board on the surgeon side console (ssc).The customer rebooted the system to resolve the error.The tse informed the customer that the error might return.The customer decided to proceed with the procedure.The customer called back during the procedure and stated arm 3 was not working.The tse reviewed the logs and noted the master tool manipulator right (mtmr) was disabled due to recoverable error 25580 on the remote arm controller (rac).The tse helped the customer perform a hard power cycle on the system; however, error code 25580 returned along with a non-recoverable error code 17.The customer converted the procedure from a da vinci robotic surgery to a laparoscopic surgery.The procedure was completed with no injury to the patient.

• Brand Name: DA VINCI XI
• Type of Device: SURGEON SIDE CONSOLE, RECONDITIONED
• 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: 10117308
• MDR Text Key: 229528891
• Report Number: 2955842-2020-10533
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380723-02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2018
• 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