MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2608-6
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during ent (ear, nose, and throat) operation, the two devices' tips were rotating and getting stuck.As a result, the operating surgeon's hand was burned.The two devices were replaced in order to complete the case.
Additional Manufacturer Narrative
D10 concomitant product: e2608-6, e2608-6 15cm disp h/s suct coag 8frx25 (lot#s24ke004).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.
Additional Manufacturer Narrative
Additional information: g3, h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the button tactile is poor, difficult to press the button.Self-activation test failed as the device triggers the resistor box.The device was detected by the lab generator.As soon as the device was plugged in, the error e322 message appears indicating the hand switch is pressed.Device was disassembled and a wire failure was found.The wire damage likely is the cause of the device alarm.The reported conditions were not replicated.The device was brought to the attention of manufacturing.They determined the damage to the device was unlikely done during the manufacturing process.It was reported that the device was difficult to assemble and caused a device-related burn.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected unreported conditions: of cable/wire damage and button/switch failure.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.
Additional Manufacturer Narrative
Additional information: d4 (udi), d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based on all information received.The device was available for evaluation.Visual inspection found no notable conditions.However, the button exhibited poor tactile response and was difficult to press.The device failed the self-activation test, as it triggered the resistor box.Despite this, the device was detected by the lab generator.Upon connection, an e322 error message appeared.The device was disassembled, and wire failure was identified.This wire failure is likely the root cause of the device alarm.It was reported that the device was difficult to assemble and caused a device-related burn.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation did identify unreported conditions, including cable/wire damage and button/switch failure.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 & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21808334
• Report Number: 3006451981-2025-00037
• Device Sequence Number: 7350756
• Product Code: GEI
• UDI-Device Identifier: 20884521039015
• UDI-Public: (01)20884521039015(17)291011(10)S24KE004
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K791752
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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: E2608-6
• Device Catalogue Number: E2608-6
• Device Lot Number: S24KE004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 07/12/2025; 08/06/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 07/14/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown