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

Model Number 380677-06

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

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

Event Date 12/17/2020

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 found that the ssc touchpad¿s screen was black upon system startup.The fse replaced the touchpad and the system was tested and verified as ready for use.Isi received the ssc touchpad involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed/replicated the reported complaint.Visual inspection was performed found the unit was in a good condition.The unit was installed into the test system.The touchpad¿s screen was black and the unit triggered error 75.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.An isi tse reviewed the logs during troubleshooting and noted error 75 pointing to the touchpad on the ssc, along with multiple communication errors.No image or video was provided.This complaint is reportable due to the following: it was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the customer encountered non-recoverable errors.The customer was grasping tissue with two instruments at the time of the event.Intuitive surgical, inc.(isi) technical support engineer (tse) helped the customer release the instrument using instrument release kit and perform a hard power cycle on the system.The error returned after power cycling the system.The customer elected to use another ssc for the procedure.Isi followed up with the initial reporter and confirmed that the procedure was completed robotically using the second ssc with no injury to the patient.Based on the information provided, the failure mode is reportable because system unavailability after the start of a surgical procedure (first port incision) could lead to the procedure to be converted/aborted.While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the customer encountered non-recoverable errors on the system.The customer was grasping tissue with two instruments at the time of the event.An intuitive surgical, inc.(isi) technical support engineer (tse) helped the customer release the instrument using the instrument release kit and perform a hard power cycle on the system.The error returned after power cycling the system.The customer elected to use another surgeon side console (ssc) for the procedure.Isi followed up with the initial reporter and confirmed that the procedure was completed robotically using the second ssc with no injury to the patient.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 11145119
• MDR Text Key: 239442436
• Report Number: 2955842-2021-10019
• 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: health professional,other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-06
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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