MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-23

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

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 isi fse was not able to replicate the customer-reported error 23.The customer had the faulted surgeon side console (ssc) connected to another xi system for repair, so the system logs from the time of the initial incident were not accessible.The fse replaced the cfg remote arm controller (rac) as a precaution.The system was tested and verified as ready for use.Isi received the cfg rac part involved with this complaint and completed the device evaluation.Failure analysis investigation could not reproduce, however, confirmed the error via system logs.Remote logs showed 40 occurrences of error 23 during the 60 days prior to the rma creation date.The rac was installed on a printed circuit assembly (pca) test system which launched in maintenance mode to program software, then power cycled 10x and sine cycled for 5 minutes without an error.The system launched in normal mode and both mtms were utilized to manipulate the orientation of a known-operational endoscope installed on the universal surgical manipulator (usm) 2.As a preventative maintenance measure, the rac controller module (rcm) board will be replaced, contact grease will be applied to all ports and the low voltage differential signaling (lvds) connectors will be cleaned.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted 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: during a da vinci-assisted surgical procedure, the surgeon was not able to take control of the left master tool manipulators (mtm) after docking.The issue was not resolved through troubleshooting so the site converted the procedure to another surgeon side console.System unavailability after the start of a surgical procedure could lead to the procedure being converted/aborted and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr field information: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.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 hysterectomy surgical procedure, that an error 23 was displayed during setup.The customer called in after they were not able to take control of the left master tool manipulators (mtm) after docking.Logs showed the left mtm left was having faults and it was disabled.The site tried power cycling with no change; the error came back at power-up.The site said this was a single console system but they had another console that they could use if needed.The site said they would call back with questions if needed.Later, an intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and noticed that instruments were installed while using a different surgeon side console (ssc).The confirmed that the procedure was converted to another da vinci console.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 13040085
• MDR Text Key: 290149196
• Report Number: 2955842-2021-11775
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/23/2021

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: 380677-23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Female