MAUDE Adverse Event Report: MEDTRONIC (COVIDIEN); COVIDIEN CAUTERY DEVICE IN LARGE ENT

Catalog Number	DYNJ901761C
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a fire occurred while the cautery device was being used in an unidentified procedure.The mode, use, and settings of the cautery device were not reported.Information about the generator used at the time of the incident was not reported.No impact to the patient, the patient's stability, or to the unidentified procedure was reported.No injury to a staff member was reported.No sample was returned to the manufacturer for evaluation.Despite multiple good faith efforts to obtain additional information, the facility contact was unable or unwilling to provide any further patient, product, or procedural information to the manufacturer.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a fire occurred while the cautery device was being used in an unidentified procedure.

• Common Device Name: COVIDIEN CAUTERY DEVICE IN LARGE ENT
• Manufacturer (Section D): MEDTRONIC (COVIDIEN); 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 7530702
• Report Number: 1423395-2018-00025
• Device Sequence Number: 176070
• Product Code: LRO
• UDI-Device Identifier: 10889942793419
• UDI-Public: 10889942793419
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJ901761C
• Device Lot Number: 181B1835
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/21/2018
• 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