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

Model Number 380677-10

Device Problem Poor Quality Image (1408)

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

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - intuitive surgical, inc.(isi) received both the hrsv and the pmsc involved with this complaint.Failure analysis was able to confirm the reported failure on the pmsc.The pmsc was installed into a test system and there was video from the ssc and the vision side console.However, the video output could not be tested due to the dvi connector having bent pins.The failure analysis for the hsrv has not been completed and is still in progress.A follow-up mdr will be submitted once the device evaluation has been completed or if additional information is received.The 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 the reported malfunction were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy procedure, no vision was observed in the left eye.The customer tried a new scope but the issue was not resolved.The intuitive surgical, inc.(isi) technical service engineer (tse) advised to power cycle the system and cycle the breaker on the back of the surgeon side console (ssc) and remove the cable from the back of the ssc but 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 patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.To resolve the issue, the fse replaced the left high resolution stereo viewer (hsrv) and the personality module surgeon console (pmsc).The hrsv is located on the surgeon side console and provides the 3d image captured from the endoscope inserted in the patient.The pmsc is a module that consists of 5 interface boards.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has completed the device evaluation for the high resolution stereo viewer.Failure analysis confirmed the customer reported failure mode.There was no image due to the main board having a defect.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7959062
• MDR Text Key: 123521377
• Report Number: 2955842-2018-10601
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES