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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
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
Da vinci robot displayed error prior to start of case.Leadership notified of the event.Troubleshooting of robot instructed by davinci vender.Following unsuccessful troubleshooting, the patient was moved to an available room next door safely by anesthesia personnel and nurses.All precautionary measures were followed.Error message with da vinci robot noted after start of case.Required patient (pt) to be moved to another room to continue case.No other impact to pt.Event reached patient, no harm/no detectable harm.Erbe generator was the problem, all erbe generators for the da vinci robots have been replaced by vender¿ returned to service.Manufacturer response for da vinci surgical system, da vinci surgical system (per site reporter).Troubleshooting of robot instructed by davinci vender.
 
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Brand Name
ENDOWRIST
Type of Device
SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key14885395
MDR Text Key295124057
Report Number14885395
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 Other Health Care Professional
Type of Report Initial
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/23/2022
Event Location Hospital
Date Report to Manufacturer07/01/2022
Type of Device Usage Unknown
Patient Sequence Number1
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