MAUDE Adverse Event Report: COVIDIEN INSULATED BLADE ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E1455-4
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When the physician went to use the bovie tip inside the patient he noticed that the plastic insulation had broken off inside the patient.

• Brand Name: INSULATED BLADE ELECTRODE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 18239411
• Report Number: MW5148592
• Device Sequence Number: 6644756
• Product Code: GEI
• UDI-Device Identifier: 10884521713185
• UDI-Public: (01)10884521713185
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/27/2023

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 Lot Number: 230030067R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female