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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI XI ENDOSCOPE WITH CAMERA, 8,MM 30 DEGREE; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
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INTUITIVE SURGICAL DA VINCI XI ENDOSCOPE WITH CAMERA, 8,MM 30 DEGREE; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Catalog Number 470027
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2019
Event Type  malfunction  
Event Description
During robotic hernia the robot would alarm and a recoverable fault, 4531, would appear on the screen stating right video connection lost.After this happened twice, rn called the 800 intuitive support number.She was told that the problem was with the camera not the robot.She was advised to unplug and re-plug in the camera 5 times and if this continued to use a different camera.She was also advised to have central processing clean the connection very well.This continued to happen but another camera was not available so we proceeded with the surgery.Throughout the surgery the same code appeared on our screen several times.
 
Event Description
During robotic hernia the robot would alarm and a recoverable fault, 4531, would appear on the screen stating right video connection lost.After this happened twice, rn called the 800 intuitive support number.She was told that the problem was with the camera not the robot.She was advised to unplug and re-plug in the camera 5 times and if this continued to use a different camera.She was also advised to have central processing clean the connection very well.This continued to happen but another camera was not available so we proceeded with the surgery.Throughout the surgery the same code appeared on our screen several times.
 
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Brand Name
DA VINCI XI ENDOSCOPE WITH CAMERA, 8,MM 30 DEGREE
Type of Device
SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL
1266 kifer rd
sunnyvale CA 94086
MDR Report Key8744552
MDR Text Key149542768
Report Number8744552
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number470027
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2019
Date Report to Manufacturer06/28/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Age13140 DA
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