MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; VISION SIDE SYSTEM

Model Number 381121-28

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 05/02/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was reproduced based on the field evaluation.The field engineer (fse) found a burnt spot inside the digital video interface (dvi) video output port of the left eye, which could have happened due to improper dvi connections.The fse replaced the pmav and the system was tested and verified as ready for use.Isi has not received the pmav involved with this complaint.Therefore, the root cause of the alleged customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the unit is returned (post failure analysis evaluation) or if additional information is received.A site history was performed and no other complaints related to the event were found.As of the date of this report, no image or video of the system error was received for review.A system log review was performed and the error 307 was noted.Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopic surgery.Although there was no patient injury, the product malfunction could cause or contribute to an adverse event if the failure were to recur.

Event Description

It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the system had error 307.The customer found the issue while inserting the instrument in the arms.The technical service engineer (tse) found that the personality module audio / video (pmav) node was not responding.The customer performed the hard power cycle, reseated the fiber optic cable on the vision side cart (vsc) and the system booted up with the same error 307.The procedure was converted to laparoscopic surgery.Intuitive surgical inc.(isi) followed up with the tse and obtained the following additional information: there were no issues noted during system set up and the system booted up normally.There were no issues with the port placements.The surgical staff did not observe any outside influences that were impeding movement of the system or patient side monitor (psm).The customer did not attempt to reset the instrument or drape.The procedure was not started when the issue occurred, but ports had been placed.As of the date of this report, it is unknown if there were any post-surgical complications to the patient.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

4307 - an isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was reproduced based on the field evaluation.The field engineer (fse) found the burnt spot inside the digital video interface (dvi) video output port of the left eye, which could have happened due to the improper dvi connections.The fse replaced the personality module audio/video (pmav) and the system was tested and verified as ready for use.Isi received the pmav involved with this complaint and completed the device evaluation.The customer reported complaint was replicated.The pmav was installed and tested in the printed circuit assembly (pca) test system.It failed with error 307, unable to configure or program the pmav.Digital video interface (dvi) port on vol2 was damaged.Based on the information provided at this time, this complaint remains a reportable event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) contributed to the procedure being converted to laparoscopic surgery.Although there was no patient injury, the product malfunction could cause or contribute to an adverse event if the failure were to recur.

Manufacturer Narrative

Updated information can be found in the following fields: g4, g7, h2, h10.Corrected information can be found in the following fields: g5 and h10.Field g5 is updated with the product's 510k number.The blank mdr fields noted in field h10 of the initial mdr should have included the following: "the expiration date in section d4 is not applicable.".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI XI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10081513
• MDR Text Key: 233243556
• Report Number: 2955842-2020-10509
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-28
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES