DA VINCI SI SURGICAL SYSTEM

Report

Report Number: 2955842-2010-00442
Event Type: Other
Date Received: October 15, 2010
Date of Event: September 16, 2010
Report Date: September 16, 2010
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K081137
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) CONCLUDED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE SURGEON SIDE CONSOLE (SSC) POWER SUPPLY. THE SSC POWER SUPPLY CONVERTS THE AC VOLTAGE FROM THE WALL OUTLET TO DC VOLTAGE FOR USE BY THE SYSTEM. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED POWER SUPPLY. AS OF (B)(4) 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED A PATIENT CART RUNNING ON BATTERY MESSAGE DISPLAYED ON THEIR MONITOR. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE VERIFIED THAT THE ELECTRICAL CABLES WERE PROPERLY PLUGGED INTO THE WALL SOCKET AND THE BREAKER WAS IN THE CORRECT POSITION. THE SITE ALSO REMOVED INSTRUMENTS FROM THE SYSTEM, APPLIED EMERGENCY POWER OFF TO THE SYSTEM AND TURNED OFF THE BREAKER ON PATIENT SIDE CART BEFORE RESTARTING THE SYSTEM. THEY SYSTEM MESSAGE CONTINUED. THE SITE RE-INSTALLED THE INSTRUMENTS BUT COULD NOT ACTIVATE THE INSTRUMENTS FROM SURGEON SIDE CONSOLE. THE MONITOR DISPLAYED THE MESSAGE NO BATTERY BACKUP. AT THIS TIME, THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DA VINCI SI SURGICAL SYSTEM	ENDOSCOPIC INSTRUMENT CONTROL SYSTEM	NAY	INTUITIVE SURGICAL,INC.	IS3000 A6.0P4

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU