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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SI VISION SIDE SYSTEM

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INTUITIVE SURGICAL, INC DA VINCI SI VISION SIDE SYSTEM Back to Search Results
Model Number 380990-11
Device Problem Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc (isi) received the unit involved with this complaint and completed the device evaluation. Failure analysis was unable to confirm the reported failure. A visual inspection was performed and the front ventilation was found to have debris stuck on it. The unit was installed into pca system and a power cycle was performed and no error had occurred. A white balance laser check was completed and it was good. 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 inguinal hernia procedure, the customer was getting a red hue when the illuminator was turned on. The customer had tried multiple endoscopes and tried power cycling the system but the red hue was still present. The customer indicated that when the illuminator was off, the image had a green hue to it. The intuitive surgical, inc. (isi) technical support engineer (tse) had the customer perform a hard cycle on the vision side cart (vsc) and to check the camera cable while the system was off but the system powered back on with the same issue. Further troubleshooting was performed but the issue could not be resolved. At that time, the surgeon made the decision to convert and complete the procedure using traditional laparoscopic techniques. There was no report of patient harm, adverse outcome or injury.
 
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Brand NameDA VINCI 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 Key7826034
MDR Text Key118752630
Report Number2955842-2018-10493
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
Report Date 08/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number380990-11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2013
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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