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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI MONOPOLAR CURVED SCISSORS DA VINCI MONOPOLAR CURVED SCISSORS-MONOPOLAR CAUTERY

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INTUITIVE SURGICAL INC. DA VINCI MONOPOLAR CURVED SCISSORS DA VINCI MONOPOLAR CURVED SCISSORS-MONOPOLAR CAUTERY Back to Search Results
Lot Number M10100714
Event Date 09/21/2010
Event Type  Malfunction  
Event Description

Pt had da vinci assisted supracervical hysterectomy with right salpingo-oophorectomy. Halfway through the cautery of the cervix, there was a sudden smoking from the monopolar cautery cord where it attached to the instrument outside of the pt's body. Immediately all cauterization was stopped and the instrument and the cord were replaced. There was issue with any thermal damage to the pt's skin or tissues internally. The smoke was limited to the cord where it attached to the instrument.

 
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Brand NameDA VINCI MONOPOLAR CURVED SCISSORS
Type of DeviceDA VINCI MONOPOLAR CURVED SCISSORS-MONOPOLAR CAUTERY
Manufacturer (Section D)
INTUITIVE SURGICAL INC.
sunnyvale CA 94086
MDR Report Key1894080
Report NumberMW5018072
Device Sequence Number1
Product CodeNAY
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 11/02/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/02/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberM10100714
OTHER Device ID NumberREFERENCE #
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes

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