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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS2000 A51P8
Device Problems Break (1069); Output Problem (3005)
Patient Problem Blurred Vision (2137)
Event Date 02/19/2013
Event Type  Other  
Event Description
It was reported that during a da vinci s prostatectomy procedure, the customer experienced a problem with blurry vision on the right eye of the surgeon side console. With the assistance of isi technical support engineer (tse), the customer exchanged the scope and found it to be damaged. According to the customer, the gasket seal was broken. They installed a new endoscope, but the right eye was too cloudy. They replaced the camera head and the blue vision cable, but they had no image at all. There were no errors reported from the da vinci robot system. The surgeon decided to convert the procedure to traditional open surgical techniques to complete the planned procedure.
 
Manufacturer Narrative
The field service engineer visited the site to inspect the endoscope, the blue vision cable, and the camera head. The fse could not find any issues with the camera head or with the blue vision cable. The system was repaired by replacing the defective endoscope. The system endoscope projects light from the illuminator onto the surgical site and the video image of the surgical site captured by the endoscope is sent back through left and right channels to the camera head. Upon replacement of the endoscope, the fse tested the system and found it to be working to manufacturer's specifications with no defect or malfunction. The endoscope was returned to the original equipment manufacturer (oem) for evaluation. The oem confirmed that the endoscope was received with mechanical damage to distal window assembly hermetic seal resulting in fluid invasion and subsequent minor damage to optical components. On (b)(4) 2013 the da vinci robot coordinator provided additional information regarding the reported event. She indicated that the planned surgical procedure was converted to open due to the vision issue. She also indicated that the patient didn't experience any complications, and the patient was released from the hospital. She also indicated that since the fse repaired the da vinci robot system, they have not experienced any re-occurrence of this issue.
 
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Brand NameDA VINCI S SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
tabitha reed
1266 kifer rd, bldg 101
sunnyvale, CA 94086
MDR Report Key3015980
MDR Text Key21294203
Report Number2955842-2013-00935
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K063220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/19/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS2000 A51P8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/19/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/21/2013 Patient Sequence Number: 1
Treatment
DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES
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