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

Model Number	E2350H
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, prior to use, the hand switch was unresponsive.It was replaced with new device.There was no patient inv olvement.Medtronic's initial evaluation of the incident found the pencil gave off an alarm when connected to the self-activation box.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the no issues were noted with button tactile.The pencil gave off an alarm when connected to the self-activation box.Error e322 was displayed when the pencil was connected to the generator.The device could not be used.The device was brought to the attention of manufacturing for a self-activation issue.It was reported that the device did not activate.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of alarm activation.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, prior to use, the hand switch was unresponsive.It was replaced with new e2350h.There was no patient inv olvement.Medtronic's initial evaluation of the incident found the pencil gave off an alarm when connected to the self-activation box.
Additional Manufacturer Narrative
Additional information: d3 (mfr name, street 1, mfr city and mfr region), d4 (udi), g3, h3.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found no notable conditions.Functional testing noted that there were no issues noted with button tactile.The pencil gave off an alarm when connected to the self-activation box.Error "e322" was displayed when the pencil was connected to the generator.The device could not be used.It was reported that the device did not activate.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: there was an alarm activation.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana,mx CO 80301 3299
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20409299
• Report Number: 1717344-2024-01940
• Device Sequence Number: 9105262
• Product Code: GEI
• UDI-Device Identifier: 10884524000626
• UDI-Public: (01)10884524000626(17)290331(10)241130268R(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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: E2350H
• Device Catalogue Number: E2350H
• Device Lot Number: 241130268R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 12/13/2024; 07/09/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/18/2024; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown