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

Model Number	E1455-4
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When using the 4" insulated bovie with the extended tip, in a small incision left breast, the skin edge was burned.There was a black mark on the insulation at the site of impaired integrity of the insulation.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10634554
• Report Number: 10634554
• Device Sequence Number: 19466845
• 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): 09/24/2020
• Report Date (Section F): 09/24/2020

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 Model Number: E1455-4
• Device Catalogue Number: E1455-4
• Device Lot Number: 200620344R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2020
• 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: 76
• Date Report Sent to FDA: 09/24/2020