MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PULSAR II GENERATOR-REFURB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS100-102RF
Medical Device Problem Codes	Fire (1245); Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
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
Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a generator and a handpiece.It was reported that they had an issue with a plasma blade during a clinical case.It was stated that the "tip started on fire, patient not affected¿.No injury to patient was reported, and the plasma blade was replaced immediately.

• Brand Name: PULSAR II GENERATOR-REFURB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 9911006
• Report Number: 1226420-2020-00049
• Device Sequence Number: 3296370
• Product Code: GEI
• UDI-Device Identifier: 00643169078444
• UDI-Public: 00643169078444
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K102029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

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 Model Number: PS100-102RF
• Device Catalogue Number: PS100-102RF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 83