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

Model Number 380677-21

Device Problems No Display/Image (1183); Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

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 replaced the high resolution stereo viewer (hrsv) on the surgeon side console (ssc) to address the loss of vision in the left eye.The system was tested and verified as ready for use.The hrsv has been received by isi, but analysis has not been completed.A follow-up mdr will be submitted following analysis completion and if additional information is received.The isi tse reviewed logs during troubleshooting with the customer and noted error 119, pointing to low current issue with the hrsv on the ssc.No image or video of the event was provided.This complaint is reportable due to the following: 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 the 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 total hysterectomy surgical procedure, the customer encountered left eye video loss on the surgeon side console (ssc).The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed logs and noted error 119, pointing to a low current issue with the high resolution stereo viewer (hrsv) on the ssc.The surgeon continued the procedure with a second ssc.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.

Manufacturer Narrative

D02 intuitive surgical, inc.(isi) received the hrsv monitor involved with this complaint and completed the device evaluation.Failure analysis confirmed/replicated the reported complaint.The unit was noted to have no image due to a main circuit board failure.

• 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
• MDR Report Key: 11136585
• MDR Text Key: 241053869
• Report Number: 2955842-2021-10008
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-21
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.