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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  No Answer Provided  
Manufacturer Narrative

The site's risk management department has been contacted to obtain additional details related to this event. As of the date of this report, additional information has not been provided to support the reported event. Isi will continue to make attempts to gain additional information and will provide the fda with a follow up report once the additional information becomes available.

 
Event Description

The patient posted a comment on an isi website, called patient stories, where she reported the following story. After a da vinci hysterectomy procedure, the patient was reported having a long recovery and post operative uncomfort. Over a week post op, the patient underwent a pelvic exam which resulted in the discover of a tear and an infection. A second surgery was required to repair the tear; however, one month after the second surgery, the patient was experiencing pain during intercourse which resulted in an emergency room visit.

 
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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
karen uyesugi
1266 kifer rd, bldg 101
sunnyvale , CA 94086
MDR Report Key1985870
Report Number2955842-2011-00046
Device Sequence Number1
Product CodeNAY
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberIS2000 A5.1P8
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received01/13/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2008
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: 02/11/2011 Patient Sequence Number: 1
Treatment
DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES AND ES
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