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

Model Number	E2350H-GNSB
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
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 an axillary node dissection, the cautery tip caught fire.It had been used to dissect tissue earlier in the case, at the time it caught fire it was being held against a metal instrument to cauterize a vessel.There was no harm to the patient.

• 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: 11371811
• Report Number: 1717344-2021-00287
• Device Sequence Number: 19768950
• Product Code: GEI
• UDI-Device Identifier: 10884524002217
• UDI-Public: 10884524002217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: E2350H-GNSB
• Device Catalogue Number: E2350H-GNSB
• Device Lot Number: 201530108R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 118