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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A60P9B
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the illuminator involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. The unit was installed into a test system and it failed with a blue image. 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 at the start of a da vinci-assisted surgical procedure, the customer observed a blue tint in the vision. Intuitive surgical, inc. (isi) technical support assisted the customer with troubleshooting but the vision issue persisted. It was reported that the patient had already been under anesthesia for a couple of hours at the time of the issue. Isi obtained the following additional information from the initial reporter regarding the reported event: the system was inspected prior to use. Due to the reported vision issue, the surgeon made the decision to abort the planned procedure. The procedure is still pending to be rescheduled. When the procedure was aborted, the patient was already administered anesthesia and the surgical port for the camera was placed. There was no report of patient injury or harm. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure. The fse replaced the illuminator to resolve the issue. The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.
 
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Brand NameDA VINCI SI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key6732462
MDR Text Key80698544
Report Number2955842-2017-00470
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A60P9B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2013
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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