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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 380990-11
Device Problems Calibration Problem (2890); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the illuminator associated with this complaint and completed the device evaluation. Failure analysis was able to reproduce the reported failure. Visual inspection found the front ventilation window with a lot of dirt. The unit was then installed on a test system and it failed the white balance test. 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 inguinal hernia repair procedure, the customer experience white balance calibration failures. The intuitive surgical, inc. (isi) technical support engineer (tse) had the customer power cycle the system, verify the light cable was fully seated, confirm that fluorescence was off and restore factory default settings but the issue persisted. The customer then installed light guide into an alternate light source and white balance calibration passed. However, 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. An isi field service engineer (fse) was dispatched to the facility and was able to confirm the customer 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.
 
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Brand NameDAVINCI SI
Type of DeviceVISION SIDE SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7585226
MDR Text Key110575865
Report Number2955842-2018-10277
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 other
Reporter Occupation
Type of Report Initial
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2018
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 Manufacturer05/30/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2013
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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