MAUDE Adverse Event Report: COVIDIEN LLC EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E1455-4
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While using the bovie with an insulated 4" electrode blade in the incision, working with the bovie tip into the lateral side of the breast, surgeon heard a pop sound and noted 3 areas at the edge and under the left breast incision where tissue had been burned during cauterization in incision.Upon examination of 4" bovie tip a black circular mark was noted within the insulated coating possibly having caused an arc during cauterization.Bovie setting were 35 cut pure and 35 coag fulgurate.It was confirmed the bovie pad was securely on the patient.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8935020
• Report Number: 8935020
• Device Sequence Number: 13560571
• Product Code: GEI
• UDI-Device Identifier: 10884521713185
• UDI-Public: (01)10884521713185
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/30/2019
• Report Date (Section F): 07/30/2019

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: No Information
• Device Model Number: E1455-4
• Device Catalogue Number: E1455-4
• Device Lot Number: 72440024X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 60
• Date Report Sent to FDA: 07/30/2019