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

Model Number 381121-23

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

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse confirmed hard non-recoverable 1152 errors and the original endoscope controller (ec) had to be replaced.Isi received the ec involved with this complaint and completed the device evaluation.Failure analysis (fa) stated that the reported problem was confirmed.This unit was installed into the test system and it failed with error 48204 (light engine sensor self-test failed) and the image was green due to video test.Further troubleshooting found that the light engine was the cause of the issue.No images or videos were shared for the event.This complaint is being reported based on the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the endoscope controller had repeated faults.System unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted to an open surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted colectomy surgical procedure, at the start of the case, the customer was getting endoscope errors.The intuitive surgical, inc.(isi) technical support engineer (tse) was contacted and reported that the logs showed errors, 45312, 48355, 48221, 48216 on the endoscope connector (ec)/scope.The tse had the staff reseat the scope five times at the vision cart, but here was no change.The staff tried a second scope with no change.The tse had the staff reseat that scope five times, but there was no change.The staff brought in a third scope and the left eye was white.At that point the doctor elected to convert to open surgery.There was no report of patient injury.Isi followed up with the initial reporter and obtained the following additional information: there were no issues noted during the set up of the system.The system was not inspected prior to use.There were no issues with port placement.The procedure was completed successfully via open surgery and there was no patient injury.Information regarding patient demographics, relevant testing, and medical history was requested, however the reporter was not able to provide this information.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 11085156
• MDR Text Key: 268091898
• Report Number: 2955842-2020-11410
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1