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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM

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INTUITIVE SURGICAL,INC. DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A6.0P6
Event Date 05/12/2011
Event Type  Other  
Event Description

It was reported that while performing a da vinci si hysterectomy, the left master controller did not have full control of the maryland bipolar forceps instrument during preparation of the uterine tube, resulting in non-intuitive motion and causing a small bleed on the patient's uterine tube. Coagulation was used to stop the bleed and the planned surgical procedure was completed without further incident. No post surgical complications were experienced by the patient.

 
Manufacturer Narrative

Investigation was conducted by a field service engineer (fse) who went onsite and evaluated the system. System verification testing was performed and passed. The fse was unable to replicate the customer reported failure mode and the root cause of the non-intuitive motion experienced by the customer cannot be determined. As a precaution, the fse recalibrated the left master tool manipulator (mtm). The mtm refers to the master controllers which provide the means for the surgeon to control the instruments and endoscope inside the patient from the surgeon's side console. One mtm is assigned to the surgeon's left hand and one to his right.

 
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Brand NameDA VINCI SI SURGICAL SYSTEM
Type of DeviceENDOSCOPIC INSTRUMENT CONTROL SYSTEM
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
nicky espinosa
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2120175
Report Number2955842-2011-00175
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIS3000 A6.0P6
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received05/12/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2010
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: 06/10/2011 Patient Sequence Number: 1
Treatment
DA VINCI SI SURGICAL SYSTEM, ACCESSORIES & ESU
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