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

Model Number 381121-28

Device Problem Poor Quality Image (1408)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the endoscopic controller (ec) to resolve the issue with the image quality.The system was tested and verified as ready for use.Isi received the ec involved with this complaint and completed the device evaluation.Failure analysis investigation could not reproduce the customer reported issue, however, the error was confirmed via error system logs.Error logs confirmed four occurrences of error 48204 over the past 60 days.The ec was installed with a printed circuit assembly (pca) test system to program unit software.The system was power cycled 10x without an error, then it was launched in normal mode -image quality was clear and free of noise with correct coloration.The light engine will be replaced as a preventative maintenance measure.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or procedure video was provided for review.A review of the site's system logs for the reported procedure date was conducted by isi technical support when the customer called for support.Investigation revealed multiple errors occurred during the surgical procedure that were related to the reported complaint.This complaint is being reported due to the following conclusion: the customer converted to another da vinci after the start of the procedure due to non-recoverable errors.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion.

Event Description

It was reported that during a da vinci-assisted prostatectomy surgical procedure, site had an image quality message on the vision tower screen and displayed image was green.Prior to calling tech support, the customer had attempted to use two different endoscopes with no change.The customer also stated that they power cycled the system prior to calling in, however, the issue persisted.An intuitive surgical, inc.(isi) technical support engineer (tse) assisted the caller with powering off the system and performing a hard power cycle of the vision tower.The system powered on and the message cleared; the image was normal.The customer continued with the procedure at the time of the call.The isi tse reviewed live logs and found 48204 errors pointing to the endoscope controller (ec).Site called back and stated that after the original call had ended, the vision tower image issue returned.The customer ended up switching out the vision tower and proceeded with the case using another systems vision cart.The procedure was completed with no reported injury.An isi field service engineer (fse) spoke with robotics coordinator about the issue and they mentioned of cleaning the pins with alcohol wipes.Isi followed up with the initial reporter and obtained the following additional information: the robotics coordinator was not able to provide any additional information regarding the procedure.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13765561
• MDR Text Key: 296889422
• Report Number: 2955842-2022-10607
• 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
• Reporter Occupation: Nurse
• Report Date: 02/14/2022

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• 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: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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