MAUDE Adverse Event Report: INTUITIVE SURGICAL DAVINCI SURGICAL SYSTEM; SYSTEM, SURGICAL, COMPUTER

Device Problem Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Date 02/26/2016

Event Type  Injury  

Event Description

I had a total hysterectomy on (b)(6) for endometrial cancer.My surgeon used the davinci robotic device to perform the surgery.In (b)(6), i was diagnosed with recurrent cancer and a pea-sized nodule at one of the davinci port sites was confirmed positive for endometrial cancer metastasis.

• Brand Name: DAVINCI SURGICAL SYSTEM
• Type of Device: SYSTEM, SURGICAL, COMPUTER
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 6954621
• MDR Text Key: 89671842
• Report Number: MW5072789
• 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: 10/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 68 YR
• Patient Weight: 77