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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI SYSTEM, ROBOTIC SURGICAL

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INTUITIVE SURGICAL, INC. DA VINCI SYSTEM, ROBOTIC SURGICAL Back to Search Results
Model Number VS 3000
Event Date 06/27/2012
Event Type  Malfunction  
Event Description

During robotic hysterectomy, no one was present at console to activate power source to activate pedal. However, upon advancing instruments there was smoke and a burn spot on the bipolar cautery instrument. The active esu cord had been plugged into the esu monopolar output instead of the bipolar output. There was also a burn on the patient's uterus. The robotic unit had instigated the electrical without anyone telling the panel to. The patient was having a hysterectomy so she was not harmed. ======================manufacturer response for robotic surgical system, (brand not provided) (per site reporter). ======================error is probable when using singular banana plug receptacles. There is a disposable part that is configured to eliminate the possibility. The part number is e0512. Cord may have been plugged into monopolar port when it should have been in bipolar port.

 
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Brand NameDA VINCI
Type of DeviceSYSTEM, ROBOTIC SURGICAL
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer rd
sunnyvale CA 94086
MDR Report Key2671515
Report Number2671515
Device Sequence Number1
Product CodeNAY
Report Source User Facility
Type of Report Initial
Report Date 07/12/2012
4 DeviceS WERE Involved in the Event: 1   2   3   4  
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device MODEL NumberVS 3000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2012
Device Age2 mo
Event Location Hospital

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