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

Model Number 380677-08

Device Problem Poor Quality Image (1408)

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

Event Date 03/02/2022

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 reported complaint was confirmed based on the field evaluation.The field service engineer took apart the high resolution stereo viewer and cleaned both eye pieces and cleaned off the spot on the surgeon side console.The system was tested and verified as ready for use.A review of the site's complaint history does not reveal any related complaints involving this product or this event.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 engineer (tse), investigation revealed no related errors related to the reported issue.This complaint is being classified as a reportable event due to the following conclusion: the customer stated that they had a spot in the surgeon side console.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 conversion.

Event Description

It was reported that during a da vinci-assisted simple prostatectomy surgical procedure, the site observed a spot in the surgeon side console (ssc) stating that it was possible that fluid went into the console causing a spot in one of the eyes.Customer sales representative (csr) suggested the surgeon to move to the second ssc.The technical support engineer (tse) asked if any wet cleaning was performed on ssc and site informed that one of the surgeons cleans the ssc thoroughly with a wet wipe.The tse advised the customer to clean the outside of the goggle on the ssc in case the stain was on the outside.Site continued with procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was confirmed that the surgeon completed the procedure robotically with no injury to the patient.There were no issues other than a small spot on the lens of the surgeon console.The surgeon was able to complete the case on that same console with no issues.It was suggested to the surgeon to use the other console if that small spot was not allowing him to complete the case but he was able to complete the case on the same console with the small wet spot.Customer stated that the field service engineer went out and cleaned the spot on the surgeon console lens and issue was resolved.

• 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: 13978844
• MDR Text Key: 298149669
• Report Number: 2955842-2022-10842
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-08
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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: Male