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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 Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the unit involved with this complaint and completed the device evaluation. Failure analysis reproduced the customer reported failure. The illuminator was installed into the system and it failed to power on with errors. 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 partial nephrectomy procedure, the surgeon experienced loss of light and a non-recoverable fault. The technical support engineer (tse) walked the customer through troubleshooting, however, the problem persisted. The customer found an external illuminator and installed it. The surgeon continued with the procedure. There was no report of patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure and the error was confirmed through the system logs. To resolve the issue the fse replaced the illuminator. 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 Key7065440
MDR Text Key93563097
Report Number2955842-2017-00797
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 foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2011
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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