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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. FENESTRATED BIPOLAR FORCEPS ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. FENESTRATED BIPOLAR FORCEPS ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 420205-05
Event Date 09/11/2012
Event Type  Injury  
Manufacturer Narrative

The instrument has not been returned for evaluation. The root cause of the customer reported failure mode cannot be determined. Several attempts have been made to gather additional information regarding this event without success. As of the date of this report, no additional information has been provided from the site. A follow-up medwatch report will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.

 
Event Description

On (b)(6) 2012, intuitive surgical became aware of a bowel perforation that allegedly occurred during a davinci si hysterectomy procedure performed on (b)(6) 2012. According to the information provided to the clinical sales representative (csr), the surgeon believes that the fenestrated bipolar instrument activated by itself, without the surgeon pressing the foot pedal.

 
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Brand NameFENESTRATED BIPOLAR FORCEPS
Type of DeviceELECTROSURGICAL INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.,
1266 kifer rd, bldg 101
sunnyvale CA 9408 6
Manufacturer Contact
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2807226
Report Number2955842-2012-00703
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/02/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number420205-05
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received10/02/2012
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/27/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES
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