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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 371683-05
Device Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2018
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. Visual inspection confirmed the unit was still in good condition. The unit was installed in a test system and upon start up it failed with error code 48245. Error 48245 indicates the illuminator failed to ignite. 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 prostatectomy procedure, everything went dark and there was a smell. The customer had swapped the bulb but there was no change and the illuminator would not turn back on and the display was flashing. The intuitive surgical inc. (isi) technical support engineer (tse) informed the customer that the illuminator would more than likely need to be replaced and recommended that the site to swap to another light source. The customer brought in another light source and was able to continue with the procedure. The procedure was completed with no report patient harm, adverse outcome or injury. An isi field service engineer (fse) was dispatched to the site and confirmed the customer reported event. The illuminator was replaced 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 NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale, CA 94086
4085232100
MDR Report Key7952392
MDR Text Key123375805
Report Number2955842-2018-10582
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 01/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371683-05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
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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