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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 A6.0P7
Device Problem Insufficient Information (3190)
Patient Problem Bowel Perforation (2668)
Event Date 01/17/2013
Event Type  Injury  
Manufacturer Narrative
On (b)(4) 2013, isi contacted the isi clinical sales representative (csr) who reported this event. The csr indicated that he was present during the entire surgical procedure and that he did not observe any malfunction of the site's da vinci si surgical system, instruments and/or accessories. The csr indicated that the procedure was successfully completed and there were no intra-operative complications experienced by the patient. The csr indicated that after completion of the surgical procedure, the surgeon indicated to him that he (surgeon) felt that the surgery went well. The csr indicated that he spoke to the hospital's house physician concerning this event and the house physician indicated to him that the damage found to the patient's bowel was a clean cut and did not have the appearance of damage caused by cautery energy. The csr indicated that he also spoke to the surgeon regarding this event. Per the csr, the surgeon indicated to him that it is unknown if damage to the patient's bowel occurred during creation of the port site incision or if the patient injury occurred during the surgical procedure. The csr indicated that the surgeon indicated to him that the patient has been discharged from the hospital and is recovering. No other details concerning the patient were provided by the surgeon. Isi has concluded that based on the information provided by the site, the root cause of the bowel injury sustained by the patient is indeterminable. If isi receives additional information concerning this event, a follow up medwatch report will be submitted to the fda.
 
Event Description
It was reported that approximately two weeks after successful completion of a da vinci si single site cholecystectomy procedure performed on (b)(6) 2013, the patient experienced post-surgical complications as a result of an alleged bowel perforation. Reportedly, the patient underwent a surgical procedure using open surgical techniques to repair the affected area.
 
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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 Key3007649
MDR Text Key10635173
Report Number2955842-2013-00852
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? No
Device Operator
Device Model NumberIS3000 A6.0P7
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 Manufactured01/01/2012
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 SURG SYSTEM, INSTRUMENTS, ACCSS & ESU
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