FDA Adverse Event Other Summary report: N

DA VINCI SI SURGICAL SYSTEM

MDR report key: 2843239 · Received November 21, 2012

Report

Report Number: 2955842-2012-01061
Event Type: Other
Date Received: November 21, 2012
Date of Event: October 26, 2012
Report Date: October 26, 2012
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K081137
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A FAULTY CAMERA CABLE. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON'S CONSOLE. THE SYSTEM WAS REPAIRED BY REPLACING THE DEFECTIVE CAMERA CABLE. THE DA VINCI S SURGICAL SYSTEM USER'S MANUAL EXPLICITLY STATES THAT, ENVIRONMENTAL OR EQUIPMENT FAILURES MAY CAUSE THE DA VINCI SI SYSTEM TO BECOME UNAVAILABLE. THE SURGICAL TEAM SHOULD ALWAYS HAVE BACKUP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES." AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT APPROXIMATELY 30 MINUTES INTO A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE, THE RIGHT EYE IMAGE IN THE HIGH RESOLUTION STEREO VIEWER WENT BLACK. UNABLE TO RESOLVE THE ISSUE, THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

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 A6.094

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR			DA VINCI SI SYSTEM INSTRUMENTS\| ACCESSORIES