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

Model Number	CVPLP2000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Bovie sparks and flame noted when surgical provider was using bovie tip to forcep.Flame was not near the patient, was noted on forcep and was away from the patient.The or team was notified.New bovie tip was used without further incident.All items given to biomed to evaluate.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10800798
• Report Number: 10800798
• Device Sequence Number: 14171917
• Product Code: GEI
• UDI-Device Identifier: 10884521194281
• UDI-Public: (01)10884521194281(17)230511(10)200406010X
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/27/2020
• Report Date (Section F): 10/27/2020

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 Model Number: CVPLP2000
• Device Catalogue Number: CVPLP2000
• Device Lot Number: 200406010X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/27/2020