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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 05/18/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information can be found with this complaint and completed the device evaluations. The investigation results are as follows: failure analysis (fa) was able to reproduce the reported complaint on the patient side manipulator during the cine cycle. Fa found the video in the high resolution stereo viewer to be lost intermittently. Fa was not able to reproduce the reported complaint on the personality module surgeon console. The unit was installed on the pca test system. It started up with no error. The video in both right and left eyes were sharp and clear. Performed ten power cycles and system came up with a good image in both eyes. The module passed the system test and no trouble was found. This report does not admit that the report or information submitted under this report constitutes an admission that the device, intuitive surgical, or intuitive surgical employees, caused or contributed to the reportable event.
 
Manufacturer Narrative
Intuitive surgical inc. (isi) has received the units involved with the this complaint, however, the device evaluations are still in progress and have not been completed. A follow-up mdr will be submitted once the device evaluations have been completed or if additional information is received. This complaint is being reported due 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 the reported malfunction were to recur it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the left eye in the surgeon side console (ssc) was out. The customer restarted the system but the problem persisted. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to check the left eye via the vision side cart (vsc) touchscreen and it was good. The tse had the customer restart the system again and nothing displayed in left monitor in console. The surgeon made the decision to complete the procedure without having visibility in the left eye of the ssc. 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. To resolve the issue, the fse replaced the personality module surgeon console (pmsc) and high resolution strero viewer (hrsv). The hrsv provides the video image for the ssc. The pmsc is a module that consists of 5 interface boards.
 
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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 Key6648832
MDR Text Key196700026
Report Number2955842-2017-00374
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
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 Manufacturer05/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2010
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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