MAUDE Adverse Event Report: MEDTRONIC (COVIDIEN); COVIDIEN CAUTERY DEVICE IN BREAST PACK

Catalog Number	DYNJ902703D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a bilateral mastectomy the tip of the covidien cautery device produced a flame.The facility contact stated that when the flame was identified, the tip of the covidien cautery device was changed and no further incident was reported.The facility contact stated that there was no impact or adverse effect to the patient.No further patient, product, or procedural information related to the incident was reported to the procedure pack manufacturer.It is unknown at what point in the procedure the reported incident occurred.It is unknown if the reported incident occurred during first or subsequent use of the covidien cautery device.No sample of the covidien cautery device was returned to the procedure pack manufacturer.Due to the reported flame, 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 during a bilateral mastectomy the tip of the covidien cautery device produced a flame.
Additional Manufacturer Narrative
Additional information was received by the procedure pack manufacturer related to the reported incident of a covidien cautery device tip that produced a flame during a bilateral mastectomy.It was reported that this occurred after first use of the covidien cautery device.When the flame was identified, the cautery tip was replaced with a new one.The procedure was completed without further reported incident.The patient did not require additional anesthesia to complete the procedure.There was no impact or adverse effect to the patient, the procedure, or to a staff member.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: COVIDIEN CAUTERY DEVICE IN BREAST PACK
• Manufacturer (Section D): MEDTRONIC (COVIDIEN); 710 medtronic parkway; minneapolis MN 55432 5604
• MDR Report Key: 8084118
• Report Number: 1423395-2018-00058
• Device Sequence Number: 11199358
• Product Code: FTN
• UDI-Device Identifier: 10889942857562
• UDI-Public: 10889942857562
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ902703D
• Device Lot Number: 18FBM721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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
• Patient Age: 38 YR
• Patient Weight: 64