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

Model Number	E1450X
Medical Device Problem Codes	Melted (1385); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2021
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 freon laparoscopic, the procedure was converted to open but not due to the electrode that looked charred at tip.They opened a new electrode to complete procedure.The photo attached showed that the electrode tip was melted.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a tip failure.Functional testing found the coating on the electrode tip damaged and burnt.No pieces detached from the electrode.The lot number was not reported, so the manufacturing records for this lot could not be reviewed.The packaging was not returned, defects or transportation damages that could have contributed to the reported defect could not be determined.It showed that the damaged to the coating was indicative of activating the electrode.The coating on the electrode burns off during activation and is there for ease of cleaning.It was reported that the device melted.A potentially related device issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not exceed the maximum power limits as stated in the ifu.Exceeding these power limits may result in patient injury or product damage.If the electrode is damaged, discard it.Always use the lowest power setting to achieve the desired surgical effect.The maximum power settings are detailed in the instructions for use.Some surgeons may elect to buzz the hemostats during a surgical procedure.This practice is not recommended and the hazards of such a practice probably cannot be eliminated.To minimize the risk, when using coated electrodes, place the edge of the electrode against the hemostat or metal instrument to assure a good electrical pathway.Do not activate the generator until the accessory makes contact with the instrument.Additional measures to minimize the risk of performing this technique are listed in the electrosurgical generator users manuals.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 & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 11494829
• Report Number: 1717344-2021-00394
• Device Sequence Number: 12105879
• Product Code: GEI
• UDI-Device Identifier: 10884521713154
• UDI-Public: 10884521713154
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: E1450X
• Device Catalogue Number: E1450X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1