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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DAVINCI SI VISION SIDE SYSTEM Back to Search Results
Model Number 380990-12
Device Problems Electrical /Electronic Property Problem (1198); Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
Isi received the unit involved with the complaint and completed the device evaluation. Failure analysis was able to reproduce the reported issue. The unit was installed onto a test system and it failed. White balance could not be performed due to the right eye being too bright. This problem was cause by right ccu. This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable for use after the start of a surgical procedure. Although no patient harm occurred, if this malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted prostatectomy procedure, the right eye was too bright and unclear; however, the left eye was fine. An intuitive surgical, inc. (isi) technical support engineer (tse) confirmed both 0° and 30° endoscopes had the same issue. The tse advised to verify the camera cable connections and perform white balance again; however, an error message was displayed and the issue persisted. The customer attempted using an external illuminator but again the issue persisted. At that time, the surgeon made the decision to abort the procedure post anesthesia and port placement. A field service engineer (fse) was dispatched to the facility and was able to reproduce the reported issue. The issue was resolved by replacing the double camera controller (doco). The doco is located on the vsc and it receives and processes video signals.
 
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Brand NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7318970
MDR Text Key101857628
Report Number2955842-2018-10041
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380990-12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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