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

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.

• Brand Name: SURGICAL ROBOT
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED
• MDR Report Key: 8197329
• MDR Text Key: 131763340
• Report Number: MW5082602
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 60