MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number 380610-14 A60_P7

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical inc.(isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The personality module surgeon console (pmsc) was installed into the test system and it came up with error code 48200 which indicates that an unexpected leaf board configuration was found.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 beating heart revascularization procedure, the surgeon lost vision through the right eye while looking through the high resolution stereo viewer (hrsv).The intuitive surgical, inc.(isi) technical support engineer (tse) advised the customer to disconnect the dvi cable on the back of the surgeon side console (ssc) and cycle the systems power; however, the issue persisted.An isi field service engineer (fse) was dispatched to the facility and replaced the personality module surgeon console (pmsc) to resolve the issue.The personality module surgeon console (pmsc) is a module that connects to the surgeon side console (ssc) and includes 5 smaller leaf interface boards that allow for audio/video input and output connections.

Manufacturer Narrative

On 03/20/2018, intuitive surgical, inc.(isi) received the following additional information: it was confirmed that the issue occurred prior to the start of a da vinci- assisted surgical procedure.Therefore, this mdr report is being retracted as this event is no longer a reportable event due to no patient involvement.

• Brand Name: DAVINCI SI
• Type of Device: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7320955
• MDR Text Key: 101988363
• Report Number: 2955842-2018-10043
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380610-14 A60_P7
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES