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

Model Number 381121-36

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

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

Event Date 10/27/2020

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 endoscope controller (ec) to correct the reported problem.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 investigations replicated the customer reported complaint.The unit was installed into a test system.The system started up and failed with error 319.Failure analysis found the endoscopic controller power distribution (ecpd) board was the cause of the issue.A review of the site's system logs for the reported procedure date was conducted by the isi technical support engineer (tse).The tse identified errors 307 and 319 pointing to the ec.The tse also found error 48406 pointing to the dual camera interface board (dcib) in the ec.In addition, a review of the site's complaint history identified no other complaints related to this event.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported 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.Although there was no report of patient injury, if this event were to recur it could cause, or contribute to an adverse event.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the customer called in to report that they received a non-recoverable 307 fault, and they had instruments stuck grasping tissue.The technical support engineer (tse) had the customer use an instrument release kit (irk) to open the jaws and remove all instruments.The tse noted the 307 fault was pointing to the endoscope controller (ec).The tse had the customer power down the system, cycle the circuit breakers of the vision side cart (vsc), ec and video processor (vp).The system powered back on with a 319 error.The tse reviewed the error logs, and found error 319 pointing to the ec.The tse then had the customer power down, cycle the circuit breakers of the vsc, ec, vp, and reseat the orange fiber cable between the ec and vp.The system powered back on with a 48406 error pointing to the dual camera interface board (dcib) in the ec.The customer then decided to convert to laparoscopic surgery.There was no report of patient harm, injury, or adverse outcome.

• 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: 10877405
• MDR Text Key: 217683275
• Report Number: 2955842-2020-11230
• 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: 10/27/2020

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: 381121-36
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• 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