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

Model Number	PS210-030S
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
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 healthcare provider (hcp) via a manufacturer representative regarding a handpiece.It was reported that the handpiece sheath was coming off of the tip of the blade which cause a deviation.A different handpiece was used to complete the case.There was no impact to patient outcome.Half hour delay to case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a handpiece.It was reported that the handpiece sheath was coming off of the tip of the blade which cause a deviation.A different handpiece was used to complete the case.There was no impact to patient outcome.Half hour delay to case.

• Brand Name: PLASMABLADE 3.0S
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13472323
• Report Number: 1226420-2022-00005
• Device Sequence Number: 17451198
• Product Code: GEI
• UDI-Device Identifier: 00763000059811
• UDI-Public: 00763000059811
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 02/28/2024
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 2007199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female