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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI SURGICAL SYSTEM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
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INTUITIVE SURGICAL, INC. DAVINCI SURGICAL SYSTEM SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Fever (1858); Micturition Urgency (1871); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Burning Sensation (2146); Hernia (2240)
Event Date 04/13/2017
Event Type  Injury  
Event Description
Dr (b)(6) performed a robotic hysterectomy w/ davinci robot. I experienced serious complications. I awoke w / a hematoma, severe pain, urgency to urinate, low grade fevers, a burning sensation in abdomen, and a pulling sensation that doubled me over after i urinated. When a ct was finally done, it showed vaginal cuff dehiscence, free air in the abdomen, hernia, abscess, and infection. The cuff needed to be shortened and repaired. The wounds needed to be cleaned and an abdominal drain was placed temporarily to aid healing.
 
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Brand NameDAVINCI SURGICAL SYSTEM
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
MDR Report Key8176005
MDR Text Key130985099
Report NumberMW5082241
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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