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

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).

• Brand Name: ROBOTIC LAPAROSCOPY
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• MDR Report Key: 12370354
• MDR Text Key: 268494376
• Report Number: MW5103511
• Device Sequence Number: 1
• Product Code: NAY
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• 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