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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROBOTIC LAPAROSCOPY SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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ROBOTIC LAPAROSCOPY SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) (1946); Pain (1994); Septic Shock (2068); Discomfort (2330)
Event Date 02/26/2021
Event Type  Injury  
Event Description
Diagnosed with colon cancer on (b)(6) 2020. Met virtually with dr. (b)(6) with (b)(6) the next week and was told the mass could be removed using laparoscopy with a shorter recovery time and less than a 1. 7% chance of complications. I had the surgery on (b)(6) and went home the next day. Saturday i was fine but on sunday started experiencing pain and discomfort. Was prescribed more pain meds. Ambulance called on (b)(6) and i was taken to the (b)(6) er and went straight to surgery. I ended up coding on the operating table and went into sever septic shock due to a tear in the colon. I spent 51 days in the hospital as a result of the laparoscopy. Fda safety report id# (b)(4).
 
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Brand NameROBOTIC LAPAROSCOPY
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
MDR Report Key12370354
MDR Text Key268494376
Report NumberMW5103511
Device Sequence Number1
Product Code NAY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 08/25/2021 Patient Sequence Number: 1
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