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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 380990-03
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 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the illuminator associated with this complaint and completed its investigation. Failure analysis confirmed the reported issue. The illuminator was installed into printed circuit assembly system and started up with no errors, but the lamp failed to power on due to error code 48244. The 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 the reported malfunction were to recur, it could cause or it could cause or contribute to an adverse event.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the illuminator lamp module would not turn on and the system faulted with repeated error code 48244; lamp ignition failure. The intuitive surgical inc. (isi) technical support engineer (tse) verified the repeated 48244/48245 faults in the system logs. The tse had the customer attempt to power cycle the system and verify the camera cable was fully seated at the vision tower and camera head. After troubleshooting, the reported issue persisted and at that time the customer decided to use a third party light source to complete the procedure robotically. 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 illuminator. The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.
 
Manufacturer Narrative
Further failure analysis found that the lamp would not ignite and the power supply had also failed and would be replaced as a fix.
 
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Brand NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
MDR Report Key7639716
MDR Text Key112865446
Report Number2955842-2018-10320
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 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380990-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/26/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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