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

Model Number	PS210-030S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis summary: complaint confirmed: upon receiving the package, the device was observed and seen the heat shrink component that is located under the shoulder was torn ¾¿s down on one side of the shaft of the blade.The heat shrink was still an existent of heat shrink and was able to confirm the heat shrink was assembled higher than intended defined.It was also observed upon receiving the device that it had excessive eschar buildup on and underneath the heat shrink.It was recommended to ensure the quality of the device, periodically cleaning the device, and inspecting it of any damages defined.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.It was reported that the site has had some issues with their generator and the plasma blades (blades are peeling).The site would like to send in their generator.No further information provided.No patient was involved.

• 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
• MDR Report Key: 12497268
• Report Number: 1226420-2021-00128
• Device Sequence Number: 19756668
• Product Code: GEI
• UDI-Device Identifier: 00763000059811
• UDI-Public: 00763000059811
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: 10/31/2023
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 2007232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1