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: upon receiving the package, it was also observed the suction tube, cable, and connector was cut off, discarded, and not returned by the sender.The device had to be decontaminated to proceed with the analysis due to the device having an excessive amount of eschar buildup on the blade.The blade and heat shrink were observed again after the device was decontaminated and was noticed there was a wrinkle at the top of the heat shrink but was not torn.The heat shrink was observed under the complaint lab microscope and confirmed there were also an excessive amount of eschar buildup underneath the wrinkle indicating the device was not adequately cleaned as recommended.Activating the device consistently and for long periods of time can soften the heat shrink component and fail.Guidance also recommends the settings and warnings of the device when activated/used before, during, and after surgeries.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: 12497417
• Report Number: 1226420-2021-00130
• Device Sequence Number: 11686271
• 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: 11/30/2023
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 2010029
• 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