MAUDE Adverse Event Report: DAVINCI ROBOT FOR LUNG SURGERY; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scarring (2061); Deformity/ Disfigurement (2360)

Event Date 03/23/2017

Event Type  Injury  

Event Description

As a patient i was undergoing a robotic left upper lung segmentectomy at (b)(6) performed by (b)(6) using a davinci machine.There were 4 ports used.After the operation my medical records state: "no injuries to patient" yet on my back there are extra scars which are not incision scars.And one of those incisions was not closed completely resulting in a "dent" in my back.The other abnormal scars (i have photos of them) are never explained at any time instead they are dismissed in the records and during my questioning about them to the surgeon, his staff, risk management, and the cancer center.As if none of this happened.Fda safety report id# (b)(4).

• Brand Name: DAVINCI ROBOT FOR LUNG SURGERY
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• MDR Report Key: 10138090
• MDR Text Key: 194849855
• Report Number: MW5094925
• 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: 06/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 100