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

Model Number	E7507
Medical Device Problem Codes	Material Discolored (1170); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Peeling (1999)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the procedure, the patient experienced skin peeling that was considered a burn after using the pad.There was a black circular spot found in one of the pad as shown in the pictures provided.
Additional Manufacturer Narrative
D10 concomitant products: e7507-db, e7507-db polyhesive ii rem ret el w/cord (lot#: unknown), e7507-db, e7507-db polyhesive ii rem ret el w/cord (lot#: unknown), e7507, e7507 polyhesive ii rem ret el w/cord (lot#: 251500024t).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
D10 concomitant product: e7507, e7507 polyhesive ii rem ret el w/cord (lot # 251500024t); e7507-db, e7507-db polyhesive ii rem ret el w/cord (lot # unknown); e7507, e7507 polyhesive ii rem ret el w/cord (lot # 251500024t) additional information: d3 (street 1, mfr city and mfr region), d4(model #, catalog number, expiration date, lot number and udi), g3, h4.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, 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 noted that the pouch was shown containing the device's lot number.The product was shown with a discolored area.Functional testing found that without receiving the device, a detailed investigation could not be performed for the reported complaint.The customer is advised to return the device, so a complete evaluation can be performed.If additional information is obtained, or the product is returned, this investigation will be re-opened.It was reported that there was device related burn and the pad adhesive was aggressive.The reported issues could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the pad gel was discolored.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 CO 80301 3299
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23474024
• Report Number: 1717344-2025-01434
• Device Sequence Number: 10558800
• Product Code: GEI
• UDI-Device Identifier: 10884524000077
• UDI-Public: (01)10884524000077(17)270531(10)251810287T(20)01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: E7507
• Device Catalogue Number: E7507
• Device Lot Number: 251810287T
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 01/20/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/17/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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: PLEASE SEE NOTE ON H11; SEE H11
• Patient Sex: Unknown