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

Model Number	E1452-6
Medical Device Problem Codes	Arcing (2583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
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 procedure, when the electrode needle was hooked on to the generator, the tip sparked and produced an open flame and had to be removed and replaced.The patient was on the table, but was not directly involved.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned electrode met specification.Visual inspection found that the tip of the electrode was charred with eschar.The date of expiration for the present lot is june 1, 2018, whereas the event date is jan 28, 2019.So, this is an expired lot.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found that no components were missing.The customer did not report the generator settings.Visual inspection found that the electrode tip to be charred with eschar.The tip of the electrode discolors when activated and used on tissue.This is a normal part of electrosurgery and is not considered a defect.The investigation found the device to function normally and within specifications.The instructions for use (ifu) warns: the sparking and heating associated with electrosugery 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 8387361
• Report Number: 1717344-2019-00273
• Device Sequence Number: 1785039
• Product Code: GEI
• UDI-Device Identifier: 10884521713161
• UDI-Public: 10884521713161
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 06/01/2018
• Device Model Number: E1452-6
• Device Catalogue Number: E1452-6
• Device Lot Number: 31650007X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1