MAUDE Adverse Event Report: DA VINCI ROBOT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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

Patient Problems Aspiration/Inhalation (1725); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 07/30/2013

Event Type  Injury  

Event Description

A reporter called to report the adverse event she had experienced from the da vinci robot used for her laparoscopic surgery in (b)(6) of 2013.She stated during the surgery, the device cut her arteries, she lost 2 pints of blood, and also aspirate.She said she was in icu for 8 days and had a stroke.She said she had to go to the rehab center for 2 and half weeks.She said she had to learn to talk and walk all over again.

• Brand Name: DA VINCI ROBOT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• MDR Report Key: 13692315
• MDR Text Key: 286872189
• Report Number: MW5107944
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 03/07/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2022
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White