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

Model Number	E2450H-GNSB
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation, along with an attached electrode.The returned product met specification as received.The device did not show any defects.Visual inspection showed that the tip of the electrode had eschar on it and there was partial wearing of the electrode coating.The investigation of the device did not identify anything that would have caused or contributed to the reported event.The device was plugged into a 40k ohm test box and activated in both the cut and coag mode with satisfactory results.The device was plugged into a generator and tested satisfactory.The attached electrode showed that a small part of the coating was worn away and there was eschar near the tip.The purpose of the coating is to limit the tissue from sticking to the electrode.The coating erodes as the electrode is activated.The tip of the electrode also discolors when activated and used on tissue.This effect is a normal part of electro surgery and is not considered a defective product.The investigation found the device to function normally and within specifications.The ifu warns: the sparking and heating associated with electrosurgery can provide an ignition source.Observe fire precautions at all times: when using electrosurgery in the same room with gases or flammable substances, prevent pooling of fluids and the accumulation of gases under surgical drapes or near the surgical site.Tissue buildup (eschar) on the tip of an active electrode poses a fire hazard, especially in oxygen-enriched environments, such as in throat or mouth procedures.Eschar plus high oxygen may create embers.Keep the electrode clean and free of all debris.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during open hysterectomy, the bovie tip ignited in flame during activation on tissue.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: 8525588
• Report Number: 1717344-2019-00514
• Device Sequence Number: 19501999
• Product Code: GEI
• UDI-Device Identifier: 10884524002248
• UDI-Public: 10884524002248
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K962044
• 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): 04/17/2019

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 Model Number: E2450H-GNSB
• Device Catalogue Number: E2450H-GNSB
• Device Lot Number: 82560158X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1