MAUDE Adverse Event Report: Covidien Edge; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E1455-4
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Superficial (First Degree) Burn (2685)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction

• Brand Name: Edge
• 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--439 ; +1(800)646-4633
• MDR Report Key: 50205127
• Report Number: 9610849-2026-00161
• Device Sequence Number: 16061401
• Product Code: GEI
• UDI-Device Identifier: 10884521713185
• UDI-Public: (01)10884521713185(17)301130(10)253490200R(20)01
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K981916
• 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
• Report Date (Section B): 10/02/2026

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: E1455-4
• Device Catalogue Number: E1455-4
• Device Lot Number: 253490200R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2025
• 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
• Patient Sex: Female