MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC PLASMABLADE X 3.0S LIGHT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS210-030S-LIGHT
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
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 manufacture representative (rep) regarding a generator and handpieces.It was reported that while testing the new plasmablade x light with his own system using chicken, "he used the device on a chicken breast, settings were cut 6, coag 7.He had it activated for ~15 seconds and stated he noticed it happen more the deeper he went." "if you look closely, it looked like the raw metal blade was exposed at the tip¿.Additional information from technical services seemed to show that both the coating on the blade and the heat shrink had sustained some damage.The heatshrink had a piece missing.The incident was a faulty hand piece, not the generator, so the generator was still in use.There was no reported patient impact.

• Brand Name: PLASMABLADE X 3.0S LIGHT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 10538432
• Report Number: 1226420-2020-00105
• Device Sequence Number: 16842451
• Product Code: GEI
• UDI-Device Identifier: 00763000279172
• UDI-Public: 00763000279172
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K193529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: 08/31/2021
• Device Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: SM2002111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1