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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 470049
Device Problems Device Alarm System (1012); Device Reprocessing Problem (1091); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2019
Event Type  malfunction  
Event Description
While loading the caider into the robotic arm, a fault came up stating that the instrument was not useable. The surgeon was the one that loaded it, removed it, and still got the error. We then placed a different instrument into the arm and it worked fine. The instrument did not show a red dot indicating that it was expired. I want to assure that this is not a patient safety concern at this time. The davinci robot does a safety check on every instrument that is loaded into one of the arms. If anything does not test correctly, you cannot use the instrument on the patient; it won't let it enter the patient's body. Here's the info on the instrument in question: cadiere forceps intuitive #470049, lot# n10181003 0057 ver -06. This instrument needs to be cleaned and retested to see if it will be recognized by the davinci xi robot. I have isolated the instrument in question and will be testing it in a non-patient related method. All of the xi instruments on occasion have a potential to have a haze left on them after decontamination. There is an intraop troubleshooting technique of wiping the contacts with a moist sponge that may have helped but was not utilized in this case. I have followed up by giving the staff involved this troubleshooting tip and have requested for additional training in spd for cleaning the xi instruments. The in service is scheduled in spd to refresh on the cleaning techniques and lubrication of the xi instruments.
 
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Brand NameENDOWRIST
Type of DeviceSYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale CA 94086
MDR Report Key8296706
MDR Text Key134748108
Report Number8296706
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number470049
Device Lot NumberN10181003 0057 VER -06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2019
Event Location Hospital
Date Report to Manufacturer02/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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