MAUDE Adverse Event Report: ETHICON ETHICON TROCAR

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/14/2021

Event Type  Injury  

Event Description

The reported event was days after a radical prostatectomy with lymphadenectomy procedure.An ethicon trocar caused a burn on the patient's umbilicus, patient sent the doctor pictures as it appears to be a pressure ulcer from the 12mm disposable cannula (3rd party).The surgeon said that no medical intervention, other than "neosporin" has been administered and that the patient is "doing just fine".Pr (b)(4) 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
• MDR Report Key: 17531506
• MDR Text Key: 321134573
• Report Number: MW5138420
• 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: 04/07/2022

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