MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. MEDTRONIC PLASMA BLADE X 3.0S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PS210-0305

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Description

During breast reduction surgery, 2 plasmablades were used and both failed.The first blade was not cutting tissue, although the coag was working.It looked like the coating on blade tip was peeling.The second blade was used and cut died within 10 minutes of use.Surgeon stated the tissue was fibrous fda safety report id# (b)(4).

• Brand Name: MEDTRONIC PLASMA BLADE X 3.0S
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.
• MDR Report Key: 13472650
• MDR Text Key: 285415622
• Report Number: MW5107239
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PS210-0305
• Device Lot Number: 2101137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1