MAUDE Adverse Event Report: INTUITIVE SURGICAL, INCDAVINCIINSTRUMENT, ROBOTIC SURGICAL, MONOPOLAR SCISSORS

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.

• Brand Name: DAVINCI
• Type of Device: INSTRUMENT, 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 Key: 976021
• MDR Report Key: 1008021
• Event Key: 966950
• Report Number: 1008021
• Device Sequence Number: 1
• Product Code: GEI
• 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 Received: 02/12/2008
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Physician
• Device MODEL Number: 420179
• 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 FDA: 02/12/2008
• Device Age: 1 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

#	Treatment	Treatment Date
NOT APPLICABLE
NOT APPLICABLE