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

Model Number E1455-4

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn, Thermal (2530)

Event Date 08/11/2020

Event Type  malfunction  

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10634554
• MDR Text Key: 209979177
• Report Number: 10634554
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521713185
• UDI-Public: (01)10884521713185
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E1455-4
• Device Catalogue Number: E1455-4
• Device Lot Number: 200620344R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14235 DA
• Patient Weight: 76