MAUDE Adverse Event Report: COVIDIEN VALLEYLAB SUCTION COAGULATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2505-10FR
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A combined suction/cautery device was being used during an ent procedure in the operating room by the ent surgeon.During its use for cauterization, there was a spark that came through the blue (insulation) coating.Use of the device was stopped.Device was removed from the surgical field and a new device was opened and used to complete the surgical procedure.Pinpoint size red areas were noted on the patient's lower lip and nearby skin tissue, no blistering.Fda safety report id# (b)(4).

• Brand Name: VALLEYLAB SUCTION COAGULATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10836474
• Report Number: MW5097826
• Device Sequence Number: 11519361
• Product Code: GEI
• UDI-Device Identifier: 20884521038957
• UDI-Public: (01)20884521038957
• Initial Reporter State: SD
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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 Expiration Date: 11/03/2024
• Device Model Number: E2505-10FR
• Device Catalogue Number: E2505-10FR
• Device Lot Number: S9LE006X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2020
• 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 Age: 10 YR
• Patient Weight: 37