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

Model Number	E1465
Medical Device Problem Codes	Fire (1245); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
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 exploratory laparotomy, diagnostic thoracoscopy with thoracoscopic lysis of adhesion, repair of recurrent congenital diaphragmatic hernia repair with mesh, placement of chest tube, repair of enterotomy and gastrocutaneous fistula take down, abdominal wash out, the surgeon was using electrical cautery during surgery when the bovie tip started glowing brightly and appeared to be on fire but there was no operating room fire.The surgeon immediately stopped using the cautery and noticed the needle bovie tip appeared to have melted.The tip was removed from the pencil with forceps after the generator had been unplugged and dropped into a metal basin and a new bovie pencil and tip were opened to the field.There was no patient injury.

• 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: 11662629
• Report Number: 1717344-2021-00563
• Device Sequence Number: 19587069
• Product Code: GEI
• UDI-Device Identifier: 10884521713222
• UDI-Public: 10884521713222
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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 Expiration Date: 11/30/2025
• Device Model Number: E1465
• Device Catalogue Number: E1465
• Device Lot Number: 203420317R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 55