MAUDE Adverse Event Report: COVIDIEN LP VALLEYLAB; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	CVPLP2000
Health Effect - Clinical Code	Unspecified Skin and Subcutaneous Tissue Problem (4927)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon using bovie pencil, it burnt through both gloves and injured his finger.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 24093552
• Report Number: 24093552
• Device Sequence Number: 18724141
• Product Code: GEI
• UDI-Device Identifier: 10884521834613
• UDI-Public: (01)10884521834613(17)280309(10)250106166X(20)03
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/21/2025
• Report Date (Section F): 11/21/2025

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: CVPLP2000
• Device Lot Number: 250106166X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/21/2025