MAUDE Adverse Event Report: ETHICON, INC. ETHICON TROCAR

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 10/22/2020

Event Type  Death  

Event Description

Re: allegation of patient death; ethicon trocar dear sir/madam, this letter is being sent to you regarding an event that was reported to intuitive surgical inc.{isi) on october 22, 2020.It was reported that prior to a da vinci-assisted total hysterectomy procedure, no ports had been placed yet but the patient was under anesthesia, the surgeon went to place a non-isi ethicon trocar and the surgeon struck and punctured the patient's aorta with the trocar, causing bleeding.The amount of blood loss was unknown but seven units of blood were administered.The surgeon immediately performed open surgery.The aorta was clamped and the patient went to the intensive care unit {icu).The patient allegedly expired during the night of (b)(6) 2020.The surgeon attributed the event to them hitting the patient's aorta when inserting a non-isi, ethicon, trocar.Product: ethicon trocar; (b)(6).The concomitant device, an ethicon trocar, used in the procedure was not manufactured or imported by isi and is being forwarded to your firm, per sec.803.22.265684 this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ETHICON TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 17536894
• MDR Text Key: 321043711
• Report Number: MW5143777
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1