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

Model Number	E7510-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
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
It was reported that two hours after the procedure, a third degree burn was discovered on the patient's buttock area.The pad was attached across the back and buttocks as the patient was a child.It was initially severe but gradually recovering as all available treatments for burn injury were provided.
Additional Manufacturer Narrative
Additional information: b5, g3, imf code was updated 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
It was reported that two hours after the procedure, a less than 3cmx3cm third degree burn when viewed with the naked eyes was discovered on the patient's buttock area.The pad was attached across the back and buttocks as the patient was a child.It was initially severe but gradually recovering as all available best treatments like dressing for burn injury were provided for 3 weeks.
Additional Manufacturer Narrative
Additional information: b5, g3 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
It was reported that two hours after the procedure, a less than 3cm x 3cm third degree burn when viewed with the naked eyes was discovered on the patient's buttock area.The patient was pediatric and the pad had been applied across the back and buttocks, with a patient bed cover positioned underneath the buttocks.It was initially severe but gradually recovering as all appropriate and best treatments like dressing for burn injury were provided for 3 weeks.The patient¿s condition gradually improved, the patient was subsequently discharged.
Additional Manufacturer Narrative
Additional information: g3, h6 (rfr updated).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; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25320638
• Report Number: 1717344-2026-00738
• Device Sequence Number: 5229296
• Product Code: GEI
• UDI-Device Identifier: 10884524001043
• UDI-Public: (01)10884524001043(17)261122(10)43270085X
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K822572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E7510-25
• Device Catalogue Number: E7510-25
• Device Lot Number: 43270085X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/01/2026; 06/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/01/2026; 06/04/2026; 06/08/2026
• Date Device Manufactured: 11/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 2 MO
• Patient Sex: Male