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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 A6.0P8
Device Problem Insufficient Information (3190)
Patient Problems Fever (1858); Bowel Perforation (2668)
Event Date 01/31/2013
Event Type  Injury  
Event Description
It was reported to isi that a few days after a da vinci si pyloroplasty procedure, the patient experienced problems with high fever. After consulting with his surgeon, he was brought back to the emergency room for an exploratory surgery. It was alleged that during the open traditional surgery a 3cm hole was found on the patient's bowel. It was reported that the surgeon removed 6 of the patient's colon and a colostomy bag was installed. The patient was later transferred from the intensive care unit to a private room.
 
Manufacturer Narrative
Isi contacted initial reporter clinical sales representative, he indicated that the patient was released from the hospital. Intuitive surgical contacted the hospital to request more information concerning the reported event; however, as of the date of this report no response has been received. A follow-up mdr will be submitted if additional information is received.
 
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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 Key3007560
MDR Text Key15511012
Report Number2955842-2013-00849
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
K081137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIS3000 A6.0P8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/13/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2012
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: 03/15/2013 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES
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