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

Model Number	CVPLP2000
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/06/2021
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, the surgeon had his left hand behind the abdominal wall while using the pencil device in his right hand on 30-coag power settings to open the fascial layer.The surgeon felt a shock on his left index finger while activating the device, which he described as travelling up his arm and down his leg.He suffered a small burn on his finger and was well.The device was ruled out of the incident, and since this batch of diathermy pencils have been put back into use, there was no need to follow up the incident.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 5900 genesee st; lancaster NY 14086
• MDR Report Key: 11235485
• Report Number: 1717344-2021-00128
• Device Sequence Number: 3440439
• Product Code: GEI
• UDI-Device Identifier: 10884521194281
• UDI-Public: 10884521194281
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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: 07/30/2023
• Device Model Number: CVPLP2000
• Device Catalogue Number: CVPLP2000
• Device Lot Number: 200706227X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1