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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. DA VINCI SI SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM Back to Search Results
Model Number IS3000 A60.P6
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Death (1802); Pain (1994); Septic Shock (2068); Injury (2348)
Event Date 02/11/2013
Event Type  Death  
Event Description
It was alleged that the patient had a multi-port cholecystectomy on (b)(6) 2013 that resulted in an injury to the bowel from the trocar during insertion at the beginning of the case. The patient complained about pain two days after the surgery and returned to the hospital. The patient was readmitted, allegedly septic and an emergency surgery was performed to repair the bowel. The patient expired on (b)(6) 2013.
 
Manufacturer Narrative
On (b)(4) 2013, the isi company representative was contacted to request additional information regarding the reported complaint. It was indicated that no malfunctions occurred with the da vinci si system, instruments or accessories; no complications were noted during the surgery. It was reported that the initial surgery was uneventful and there were no adhesions. The manufacturer of the trocar is unknown at the time of this report. The patient's prior medial history is not known. A review of system logs for the system allegedly used in the procedure did not produce any data for the given system at the time period indicated. A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation), or if additional information is received.
 
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Brand NameDA VINCI SI 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 Key3009969
MDR Text Key20634164
Report Number2955842-2013-00891
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 User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/18/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIS3000 A60.P6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received02/18/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2011
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: 03/18/2013 Patient Sequence Number: 1
Treatment
DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES
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