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

Model Number	E2516H
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during thoracoscopic left pulmonary bullae resection, thoracoscopic pleural repair, and thoracoscopic pleurodesis under general anesthesia with tracheal intubation, after the electrosurgical generator was connected to the host, the "electrocut" key continued to work and the head of the electrosurgical generator turned black, and the work could not be canceled until the electrosurgical pencil was separated from the host.Replacing the electrosurgical generator machine could not solve the problem, and it could be used normally after replacing the electrosurgical instrument.
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.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, during thoracoscopic left pulmonary bullae resection, thoracoscopic pleural repair, and thoracoscopic pleurodesis under general anesthesia with tracheal intubation, after the electrosurgical generator was connected to the host, the "electrocut" key continued to work and the head of the electrosurgical generator turned black, and the work could not be canceled until the electrosurgical pencil was separated from the host.The self-activation happened without pressing/pushing of activation button.Replacing the electrosurgical generator machine could not solve the problem, and it could be used normally after replacing the electrosurgical instrument.
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.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 & ACCESSORIES
• 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: 21873743
• Report Number: 1717344-2025-00565
• Device Sequence Number: 7719652
• Product Code: GEI
• UDI-Device Identifier: 10884524000053
• UDI-Public: 10884524000053
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 04/30/2025

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: E2516H
• Device Catalogue Number: E2516H
• Device Lot Number: 220170253R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 01/17/2022
• 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 Age: 16 YR
• Patient Sex: Female