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

Model Number	E2515
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	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter prior to use, the pencil would not work.Initially, the electrosurgery console was changed, but it was verified that it was the pen that did not work.The urologist and the instrumentalist, a new pen was requested in the pharmacy.There was no patient involvement.Medtronic's initial evaluation of the incident device found that the device switch resistance failure was found.There was a reading without pressing the cut button.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the troubleshooting found the pencil had no visual defects.A device switch resistance failure was found.There was a reading without pressing the cut button.The pencil alarms during testing with the resistor/self key box and generator.Error e322 is given.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 self-activation that has no relationship to the reported condition.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: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22149512
• Report Number: 1717344-2025-00737
• Device Sequence Number: 8469213
• Product Code: GEI
• UDI-Device Identifier: 10884524000497
• UDI-Public: 10884524000497
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K813071
• 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
• Report Date (Section B): 06/05/2025

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: E2515
• Device Catalogue Number: E2515
• Device Lot Number: 240290209R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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