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

Model Number	E7507
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When opening a grounding pad to use for a procedure the grounding pad appeared spotted? mold or other contaminant to the pad.Supply staff were instructed to remove this lot number from circulation in our procedure rooms as multiple products appear affected.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 23921599
• Report Number: 23921599
• Device Sequence Number: 9296239
• Product Code: GEI
• UDI-Device Identifier: 10884524000077
• UDI-Public: (01)10884524000077
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/10/2025
• Report Date (Section F): 12/10/2025

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: E7507
• Device Lot Number: 252510282T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/10/2025