MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; SURGEON SIDE CONSOLE

Model Number 380940-33

Device Problem No Display/Image (1183)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted oropharyngectomy surgical procedure, the customer lost the left eye vision on the surgeon side console (ssc).The customer reseated the endoscope, power cycled the system, and hard power cycled the ssc with no resolution.The customer confirmed that the left eye vision could be seen on the vision side cart (vsc) and on the third-party monitor.There was no report of patient injury as a result of the reported issue.Intuitive surgical, inc.(isi) followed up with the da vinci coordinator and obtained additional information: the surgeon was able to complete the procedure robotically without the left eye.

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 high resolution stereo viewer (hrsv) on the surgeon side console (ssc) to resolve the reported issue.The system was tested and verified as ready for use.Isi received the hrsv involved with this complaint and completed the device evaluation.Failure analysis investigation replicated the reported complaint.The unit was installed into the test system, and it powered up the surgeon side console (ssc) without the left eye vision.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed the following possible related system error: 119 (console hrsv low current: the hrsv monitors in ssc2 have a total current draw from the fpd that is lower than threshold).No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: the customer lost vision on the left side of the surgeon side console (ssc) during the da vinci-assisted surgical procedure.The customer was able to complete the procedure robotically; however, the loss of left eye vision could lead to the procedure being converted or aborted.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.

• Brand Name: DA VINCI SP
• Type of Device: SURGEON SIDE CONSOLE
• 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: 14116605
• MDR Text Key: 298788026
• Report Number: 2955842-2022-11062
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380940-33
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• 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