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

Model Number 380677-23

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/17/2022

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 foot pedal assembly to resolve the issue. The system was tested and verified as ready for use. Isi received the footrest energy pedal involved with this complaint and completed the device evaluation. Failure analysis investigation revealed that the footrest was reviewed in house and the camera foot pedal was found broken out. A log review confirmed the procedure date of (b)(6) 2022 on system sk4285. No image or procedure video was provided for review. Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: the customer converted to the other surgeon side console (ssc) (dual console) after the start of the procedure due to the camera pedal cover had separated from the foot tray assembly. 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 procedure change.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the camera pedal cover had separated from the foot tray assembly. Prior to calling in the issue, the surgeon had moved to the other surgeon side console (ssc) (of a dual console system) and proceeded with the case. There were no related errors in the logs. The procedure was completed as planned with no reported injury. Intuitive surgical, inc. (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: 15036895
• Report Number: 2955842-2022-13022
• 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

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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 Sex: No Answer Provided
• Patient Treatment(s): DA VINCI INSTRUMENTS AND ACCESSORIES