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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS2000 A5.1P8
Event Type  Injury  
Manufacturer Narrative

According to follow up information obtained on (b)(4) 2012 from the clinical sales representative who was present during the surgery, there were no patient complications observed during the case. The bowel perforation was discovered after the patient presented with pain at the emergency room, after which a secondary, non-robotic procedure was conducted to treat the injury. The surgeon believes the perforation may have occurred when the camera cannula was inserted, or when cutting through the fascia. The patient has since recovered and is doing well. No further information was available. There were no reports of any malfunction of the da vinci s surgical system, instruments and/or accessories, and the hospital has continued to use the system to perform surgery on patients. The instruments and accessories user manual specifically states: general precautions and warnings to minimize the risks associated with port placement, ensure the following: appropriate patient positioning to shift organs away from the port placement site. An adequate level of insufflation. Obturator tip is pointing away from major vessels, organs, and other anatomic structures. When possible, visualization of the entire insertion of the cannula using the endoscope is preferred. Moderate, controlled pressure is employed when placing the cannula and obturator. As of (b)(4) 2012, there were no reports of the same recurrence at the this hospital.

 
Event Description

It was reported that after a da vinci s hysterectomy procedure, a bowel perforation was discovered post surgery. The surgeon reportedly stated that the injury may have occurred while inserting the camera cannula, or when cutting through the fascia. No malfunction of the da vinci system, instrument(s) and/or accessories were reported during the course of this procedure.

 
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Brand NameDA VINCI S 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
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2889862
Report Number2955842-2012-01468
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberIS2000 A5.1P8
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received11/28/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/2008
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: 12/28/2012 Patient Sequence Number: 1
Treatment
DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES
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