MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM; ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

Model Number IS 3000 A6.0P8

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 07/22/2014

Event Type  Other  

Event Description

It was reported that during da vinci partial nephrectomy procedure, the system shut down.Due to the reported issue, the surgeon made the decision to convert the da vinci surgical procedure to an open surgical procedure.An intuitive surgical, inc.(isi) field service engineer (fse) visited the site the same day and replaced the core of the system.The core is being requested back for further investigation.On (b)(4) 2014, isi obtained additional information regarding the reported event from an isi fse.The system was tested prior to use and no system malfunction was observed.Approximately 20 minutes after the first incision was made, the leds on all the arms became red, there was no light source, and the system shut down.Due to the reported issue, the surgeon made the decision to convert the da vinci surgical procedure to an open surgical procedure.No further clinical information has been provided about the patient's current status.

Manufacturer Narrative

The system core has not been returned for evaluation.The root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the core is returned (post failure analysis evaluation) or if additional information is received.This complaint is being reported due to the following conclusion: the surgeon made the decision to convert the da vinci procedure to an open surgical technique due to the system shutting down.

Manufacturer Narrative

The isi core was returned to intuitive surgical, inc.(isi) for investigation with the following findings: the core was returned with the incorrect configuration.The personality module energy device (pmed) was replaced in the field which did not match the core celebration.The reported customer failure mode was replicated.Failure analysis (fa) applied power to the core and no light emitting diodes (leds) turned on, only the fans powered on.There was no power on any of the boards except the intuitive surgical core power distribution (ipd) which had a flashing red light.The red led light is for a supply fault, so failure analysis disconnected the control cable to the power supplies and measured the voltage of both supplies and they both tested at 12.05v.After further troubleshooting, fa found that the fault would go away when the personality module video acquisition (pmva) module was removed from the core.Fa removed the pmva and applied power to it and smoke came out from the vbr board.Fa replaced the video branch board (vbr) from the pmva and was able to power up the core.A component on the power module u33 caused the smoke on the old vbr board.

• Brand Name: DA VINCI SI SURGICAL SYSTEM
• Type of Device: ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 9408 6
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3972721
• MDR Text Key: 16629100
• Report Number: 2955842-2014-04653
• 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: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IS 3000 A6.0P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention