MAUDE Adverse Event Report: CONMED CORPORATION PLUMEPEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PLP2020
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mid operation the cautery began to malfunction.The cautery being used was a plume pen cautery (cautery with smoke evacuator).The smoke evacuator machine and cautery machine were simultaneously running on their own without anyone pressing the button causing a burn to the patient's right shoulder.When issue was recognized, team stopped using cautery machine and switched to a different cautery machine.Issue continued with new machine, so the plume pen cautery was completely unplugged and replaced with normal cautery pen (one provided in the ortho basic pack).After replacing plume pen cautery no other issues were noted.Surgeon was present for event.Ortho manager was notified.2 cautery machines and smoke evacuator machine were removed from the or following the procedure and replaced with new cautery machine.

• Brand Name: PLUMEPEN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd.; utica NY 13502
• MDR Report Key: 16271310
• Report Number: 16271310
• Device Sequence Number: 12650940
• Product Code: GEI
• UDI-Device Identifier: 20845854061289
• UDI-Public: 20845854061289
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2023
• Report Date (Section F): 01/18/2023

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
• Device Model Number: PLP2020
• Device Catalogue Number: PLP2020
• Device Lot Number: MM20220655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/18/2023