DA VINCI SI SURGICAL SYSTEM

Report

Report Number: 2955842-2010-00481
Event Type: Injury
Date Received: November 5, 2010
Date of Event: August 26, 2010
Report Date: August 26, 2010
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K081137
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING FOUND THE CAMERA CABLE HAD A BAD LEFT EYE CHANNEL. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON SIDE CONSOLE. THE SYSTEM WAS REPAIRED BY REPLACING THE DEFECTIVE CAMERA CABLE. AS OF NOVEMBER 4, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SITE RECEIVED A VISION SYSTEM ERROR. THE ISI REPRESENTATIVE ON SITE BEGAN TO TROUBLESHOOT AND FOUND THE LEFT EYE ON THE SURGEON SIDE CONSOLE WAS NOT WORKING. THE SURGEON AND OR STAFF WERE NOTIFIED OF THE SYSTEM STATUS; HOWEVER, THE SURGEON DECIDED TO PERFORM THE CASE WITH ONE EYE WORKING IN 2D VISION. DURING THE PROCEDURE THE PATIENT'S URETERAL WAS INJURED AND A UROLOGIST WAS CALLED IN TO PERFORM THE REPAIR AND PLACE A STENT. AT THIS TIME THE CASE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO REPAIR THE PATIENT'S URETERAL AND COMPLETE THE PLANNED PROCEDURE. THE PATIENT WAS REQUIRED TO STAY IN THE HOSPITAL AN ADDITIONAL 24-48 HOURS DUE TO THE OPEN INCISION AS WELL AS THE STENT REMOVAL. ON (B)(4) 2010, INTUITIVE SURGICAL RECEIVED MAUDE EVENT REPORT (B)(4) FOR THIS EVENT.

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 SYS, INSTRUMENTS AND ACCESSORIES