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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL ROBOT; SYSTEM, SURGICAL, COMPUTER CONTROLLED

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SURGICAL ROBOT; SYSTEM, SURGICAL, COMPUTER CONTROLLED Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Purulent Discharge (1812); Pleural Effusion (2010); Urinary Retention (2119)
Event Date 11/28/2017
Event Type  Injury  
Event Description
Had robot-assisted total hysterectomy.Ended up hospital 23 days.Had a thoracentesis to pull a liter of fluid off right collapsed lung.There was pus in fluid so had to have right thorascopic partial decortication.Kidneys problems being on head for two hours- could not urinate.Nasal gastric tube for small bowel issue.Numerous chest x-rays, ct chest with contrast, ct abdomen with contrast.
 
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Brand Name
SURGICAL ROBOT
Type of Device
SYSTEM, SURGICAL, COMPUTER CONTROLLED
MDR Report Key8197329
MDR Text Key131763340
Report NumberMW5082602
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 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/24/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age65 YR
Patient Weight60
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