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

Model Number 380677-13

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned to isi for failure analysis evaluation, however, evaluation of the unit is not yet complete.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted once the evaluation is complete and/or if additional information is received.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted salpingo-oophorectomy procedure, the right eye image through the high resolution stereo viewer (hrsv) on the surgeon side console (ssc) was black.The customer contacted intuitive surgical, inc.(isi) for technical support assistance.The isi technical support engineer (tse) instructed the customer to remove the installed instruments and then cycle the system's power and the circuit breakers on the ssc and the vision side cart (vsc), however, after the system was powered back on the issue recurred.The tse then instructed the customer to install a replacement endoscope; however, the issue persisted.At that time, the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques.There was no report of any patient harm, adverse outcome or injury.The isi field service engineer (fse) was dispatched to the hospital.The investigation conducted by the fse concluded that the vision issue experienced by the customer was associated with the hrsv.To resolve the issue, the fse replaced the hrsv.The hrsv is located on the surgeon side console and provides the 3d image captured from the endoscope inserted in the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the high resolution stereo viewer (hrsv) involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.During functional testing of the hrsv, the image displayed intermittently due to a defective printed circuit assembly (pca) main board.The pca main board will be replaced to repair the unit.

• Brand Name: DA VINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7580663
• MDR Text Key: 110466467
• Report Number: 2955842-2018-10268
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES