MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE 3.0S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS210-030S
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
Product analysis #703673622: analysis information -- 2020-03-31 15:19:22 cst pli# 20 product id#: ps210-030s.Analysis summary: complaint confirmed: upon receiving the device, the clear heatshrink was exposed.The heatshrink was removed to be able to properly test the device.The lot number that was provided from the sender was 0219082400.The device was connected to the complaint lab eprom reader and verified that the correct lot number is 0219139926 of the plasmablade 3.0s.Upon testing the device, no failures or issues were found.The device met the product specifications defined in 31-10-1369.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: PLASMABLADE 3.0S
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 9911030
• Report Number: 1226420-2020-00050
• Device Sequence Number: 16968117
• Product Code: GEI
• UDI-Device Identifier: 00643169617148
• UDI-Public: 00643169617148
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K093695
• 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 Expiration Date: 12/24/2022
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 0219139926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• 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