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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI INSTRUMENT, ROBOTIC SURGICAL, MONOPOLAR SCISSORS

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INTUITIVE SURGICAL, INC DAVINCI INSTRUMENT, ROBOTIC SURGICAL, MONOPOLAR SCISSORS Back to Search Results
Model Number 420179
Event Date 02/08/2008
Event Type  Malfunction  
Event Description

This was a patient with a known history of prostate cancer, undergoing a robotic-assisted laparoscopic radical prostatectomy and left pelvic lymph node dissection when the physicians assistant commented that he smelled garlic. Intra-operatively, it was immediately noticed that the monopolar scissors flamed, sparked and smoked at the joint when activated by the surgeon. Instrument was immediately removed from the patient. Per the surgeon there was no harm to the patient in any way. There was no thermal effect from the incident.

 
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Brand NameDAVINCI
Type of DeviceINSTRUMENT, ROBOTIC SURGICAL, MONOPOLAR SCISSORS
Manufacturer (Section F)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer road
sunnyvale CA 94086
Device Event Key976021
MDR Report Key1008021
Event Key966950
Report Number1008021
Device Sequence Number1
Product CodeGEI
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/12/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device MODEL Number420179
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 FDA02/12/2008
Device Age1 dy
Event Location Hospital
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 02/12/2008 Patient Sequence Number: 1
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