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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 A60P7
Event Date 11/27/2012
Event Type  Injury  
Event Description

It was reported that during a davinci si hysterectomy procedure, while the surgical staff was undocking the system from the patient, it was noted that the patient suffered a bowel tear during the procedure. According to the information provided by initial reported clinical sales representative, the tips of the prograsp forceps instrument were not used to grab the bowel, but the shaft of the instrument was used to retract the bowel.

 
Manufacturer Narrative

According to the information provided by the clinical sales representative, the gyn surgeon (he had performed 4-5 cases) was performing a lengthy dvh. There was a bowel perforation and tears in the serosa of the sigmoid colon, which were not noticed until the robotic portion was complete and the surgeon was ready to undock the davinci robot system. The csr was in the operating room for most of the case and did not see a specific cause for the injury. The surgeon was using a prograsp forceps instrument to push/sweep the bowel back with the shaft/wrist, but did not grab bowel. The assistant was blindly inserting a lap suction/irrigator throughout the case. Once the surgeon noticed some unusual fluid in the abdomen at the end of the case, she called a colorectal surgeon who repaired the bowel laparoscopically. The patient recovered well and had no further complications. A review of the system logs showed no system malfunction occurred during the procedure performed on (b)(6) 2012.

 
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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
tabitha reed
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key2883607
Report Number2955842-2012-01401
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/27/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS3000 A60P7
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received11/27/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/01/2012
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: 12/21/2012 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES
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