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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number A70P6B IS4000
Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/06/2017
Event Type  malfunction  
Manufacturer Narrative
Isi received the unit involved with this complaint and completed the device evaluation. The failure analysis was unable to confirm the customer reported failure. The ec was installed on the test system and it came up with no errors and good video on both eyes with no anomalies. The image was in 3d and looked normal, not magnified. The system ran 10 power cycles with this ec with no errors and no video issues. 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 hysterectomy surgical procedure, it was observed that the image was very magnified and out of 3d. The site power cycled the system but the issue persisted. The site also tried two 0 degree endoscopes and one 30 degree endoscope with no change. The zoom was set to 1x, haptic zoom was off and working distance was normal. The site pressed the restore factory settings with no change. There was no report of patient harm, adverse outcome or injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: it was confirmed that although the right eye was out and the vision was very magnified, the surgeon was able to complete the procedure as is. An isi field service engineer (fse) was dispatched to the facility and replaced the endoscope controller (ec) to resolve the issue. The ec contains a high-intensity light source to illuminate the surgical site and the electronics for processing the video images from the endoscope.
 
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Brand NameDA VINCI XI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
950 kifer rd
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd
sunnyvale, CA 
4085232420
MDR Report Key6899977
MDR Text Key87875630
Report Number2955842-2017-00635
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA70P6B IS4000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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