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

Model Number	CVPLP2000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2020
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
According to the reporter, during a procedure, about 1 hour into case, the device's tip was suddenly caught on fire.Fire did not touch patient and was promptly extinguished completely.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 5900 genesee st; lancaster NY 14086
• MDR Report Key: 10894232
• Report Number: 1717344-2020-01419
• Device Sequence Number: 11576650
• Product Code: GEI
• UDI-Device Identifier: 10884521194281
• UDI-Public: 10884521194281
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 03/12/2023
• Device Model Number: CVPLP2000
• Device Catalogue Number: CVPLP2000
• Device Lot Number: 200206013X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1