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

Model Number 381121-27

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the facility to further troubleshoot the issue.The fse replaced the endoscope controller to correct the reported problem.The system was verified and ready for use.Intuitive surgical, inc.(isi) received the endoscope controller involved with this complaint and completed the evaluation.Failure analysis was able to confirm the original complaint.The unit was placed and driven on an in-house system and failed with error 319 at system start up.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Log review could not be performed since the endoscope controller unit does not get captured by the logs.No images or videos were shared for the event.System log review done by tse show error 95: a board has reported a temperature that is beyond the operating range occurred after the start of the procedure.Error 319 node was not present at start up occurred after mid-procedure restart.Based on the information provided, this event is being reported due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.Although no patient harm occurred, if the reported malfunctioned were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the system had an overheating error.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and found error 95.A board has reported a temperature that is beyond the operating range and error 319.Node was not present at start up.The tse exhausted troubleshooting steps with the customer and was unable to resolve the issue.The customer elected to convert the procedure to a laparoscopic procedure with no reported injury.Isi contacted the customer and obtained the following information: from what she can remember, the issue happened at the beginning of the procedure.The surgical team contacted the isi tse, but the issue was not resolved.The surgeon made the decision to convert the procedure to a laparoscopic procedure once all troubleshooting steps were completed.There was no injury to the patient and she is unaware of any reports of any injury to the patient post surgical procedure.She did not have any patient-related information at the time of the call.

• 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: 10955696
• MDR Text Key: 241448358
• Report Number: 2955842-2020-11309
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-27
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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
• Patient Age: 39 YR