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

Model Number	PS210-030P
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
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 when the doctor used the handpiece at the beginning of the operation, he found sparks from the handpiece tip.The doctor tried to adjust the energy to avoid sparks, but after several tests, there were still sparks on the tip off the handpiece tip.Finally, the doctor replaced to a new handpiece to complete the operation.There was no reported impact to patient outcome.
Additional Manufacturer Narrative
Analysis summary: complaint not confirmed: upon receiving the device, it was received with dried blood on the device and eschar buildup on the blade confirming the device was used prior to receiving back the device.The device was connected to the complaint lab eprom reader and was able to confirm the lot number and the device was successfully activated prior to receiving the device.The device was then connected to the complaint lab fluke multimeter for continuity readings and confirmed it met the continuity requirements for the device.It was then connected to the complaint lab generator and tested the device on the required functional tests.No failures were found or detected when the device was tested for its functionality.The sparks were observed as well when tested for its functionality in saline and on raw chicken on both the cut and coag modes and on the required settings listed in the document that was mentioned and confirmed that the ¿sparks¿ that were produced during the analysis were normal glows that are regularly seen/produced in the devices and followed the requirements from the document mentioned and the ifu defined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PLASMABLADE 3.0PLUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11322776
• Report Number: 1226420-2021-00041
• Device Sequence Number: 4274629
• Product Code: GEI
• UDI-Device Identifier: 00643169617131
• UDI-Public: 00643169617131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 01/02/2023
• Device Model Number: PS210-030P
• Device Catalogue Number: PS210-030P
• Device Lot Number: 0219132171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1