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

Model Number	E2515H
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While opening supplies for surgical procedure the valleylab rocker pencil was noted to actually have the tip pierced through the plastic holster and sterile packaging.Supply kept and handed over to materials management.New supplies obtained.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 22506291
• Report Number: 22506291
• Device Sequence Number: 15639733
• Product Code: GEI
• UDI-Device Identifier: 10884524000046
• UDI-Public: (01)10884524000046
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025
• Report Date (Section F): 06/25/2025

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
• Device Model Number: E2515H
• Device Lot Number: 250200192R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• 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: Unknown
• Date Report Sent to FDA: 06/25/2025