MAUDE Adverse Event Report: Covidien Valleylab; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	E1551-6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Serious Injury

• Brand Name: Valleylab
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): Covidien; 200 medtronic drive; lafayette,co
• Manufacturer (Section G): Covidien; 200 medtronic drive; lafayette,co
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50849353
• Report Number: 3026612481-2026-00053
• Device Sequence Number: 9508376
• Product Code: GEI
• UDI-Device Identifier: 10884521713291
• UDI-Public: (01)10884521713291(17)300930(10)252870046R(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: E1551-6
• Device Catalogue Number: E1551-6
• Device Lot Number: 252870046R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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: Unknown