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

Model Number	E7509-B
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant medical products: e7509, e7509 rem polyhesive ii cordless x50 (lot#:251260001t).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, post operatively, the rem (return electrode monitoring) pad had caused pustules and skin loosening.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection of the photo noted skin irritation.It was reported that an adverse event occurred involving device¿patient skin interaction.The reported issue was confirmed.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; boulevard insurgentes 19030; tijuana,mx
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22892573
• Report Number: 9610849-2025-00036
• Device Sequence Number: 8957968
• Product Code: GEI
• UDI-Device Identifier: 30884524001016
• UDI-Public: (01)30884524001016(17)261231(10)250270235T(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K861036
• 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
• Report Date (Section B): 11/17/2025

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: E7509-B
• Device Catalogue Number: E7509-B
• Device Lot Number: 250270235T
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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: SEE H11
• Patient Sex: Unknown