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

Model Number	E1465-4
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/17/2018
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, the surgeon started the procedure with a smoke evacuation pencil and at one point decided to put the electrode on a standard monopolar pencil.The electrode could not be removed by surgeon's hand and opted to use a kelly clamp.Shortly after the electrode was switched back to the smoke evacuating pencil and this time the tech removed the electrode using the kelly clamp as well.This time, there were burns noticed on patient's right nipple with four small burns a less than half of one centimeter in size each so the surgeon inspected the electrode and saw clamp marks in the area of the failed part of the insulation.A new electrode was opened and used without any further issue.Burns site were treated with neosporin medication after the procedure.

• 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: 8060923
• Report Number: 1717344-2018-01470
• Device Sequence Number: 13949900
• Product Code: GEI
• UDI-Device Identifier: 10884521175525
• UDI-Public: 10884521175525
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K981916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: 11/07/2018
• Device Model Number: E1465-4
• Device Catalogue Number: E1465-4
• Device Lot Number: 32980116X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR