MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC PLASMABLADE 4.0; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS200-040
Medical Device Problem Codes	Fire (1245); Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
2 information was received from a healthcare professional (hcp) via a manufacturing representative (rep) regarding a generator and handpiece.It was reported that the tip of the handpiece began to arch, spark, and produce a visible flame during a pacemaker procedure.It was noted that there was no patient injury or adverse event and the procedure was completed with another cautery tool.The settings were cut 7 and coag 7.

• Brand Name: PLASMABLADE 4.0
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 10458013
• Report Number: 1226420-2020-00095
• Device Sequence Number: 11478639
• Product Code: GEI
• UDI-Device Identifier: 00763000059842
• UDI-Public: 00763000059842
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K073057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PS200-040
• Device Catalogue Number: PS200-040
• Device Lot Number: 2001187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1