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

Model Number	PS300-002
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event: (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During an ent case, the plasmablade device tip melted.There was no injury or harm to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During an ent case, the plasmablade device tip melted.There was no injury or harm to the patient.

• Brand Name: PLASMABLADE TNA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 6844560
• Report Number: 1226420-2017-00221
• Device Sequence Number: 13467746
• Product Code: GEI
• UDI-Device Identifier: 00643169628434
• UDI-Public: 00643169628434
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K152703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: 10/11/2019
• Device Model Number: PS300-002
• Device Catalogue Number: PS300-002
• Device Lot Number: 0212038848
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 27