MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E1450-6
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a thoracic case, the consultant asked his assistant to use the diathermy machine (setting 50) with the medium tip (with rubber shod) to touch the forceps with it.There was a flame on the diathermy tip and had to drop it on the floor and was stepped on.A new diathermy pencil with medium tip (with rubber shod) was provided and the setting on the diathermy machine was changed down to 20.Diathermy machine was checked; there were no issues and in service date, and settings used comparable to other cardiac centres.No patient harm.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8293436
• Report Number: 1717344-2019-00142
• Device Sequence Number: 16541054
• Product Code: GEI
• UDI-Device Identifier: 10884521713130
• UDI-Public: 10884521713130
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: 09/02/2022
• Device Model Number: E1450-6
• Device Catalogue Number: E1450-6
• Device Lot Number: 72400115X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1