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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 380990-09
Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical inc. (isi) received the unit involved with this complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure. The illuminator was installed into a test system and it failed to turn on the lamp module. 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 surgical procedure, the customer experienced a non-recoverable error. The intuitive surgical, inc. (isi) technical support engineer (tse) instructed the customer to verify the illuminator circuit breaker, check power cord connection and restart the system. However, the issue persisted and the customer was advised to use a third party illuminator to continue the procedure. The planned surgical procedure was completed with an alternate light source and no patient harm, adverse outcome or injury was reported. An isi field service engineer (fse) was dispatched to the facility and 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.
 
Manufacturer Narrative
Additional testing was performing on the unit involved with this complaint and found that the illuminator fuse was blown. The power failed (noisy), the front panel was scratched and will be replaced along with membrane overlay. The unit was dirty and needs to be cleaned.
 
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Brand NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
MDR Report Key7635551
MDR Text Key112755056
Report Number2955842-2018-10316
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 other
Type of Report Initial,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380990-09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/25/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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