MAUDE Adverse Event Report: Aspen Surgical Products, Inc. Medtronic Covidien 5mm Ball.; Ball Electrode

Model Number	E1564
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "it was reported that during a leep procedure and bovie settings at 75, the device insulation melted, and a piece of it fell into the patient's cavity, which was fully retrieved.There was no patient injury.".
Additional Manufacturer Narrative
The device was returned for evaluation.The device was used at 75 watts in the coag setting.Per the ifu, it states "always use the lowest power setting that achieves the desired surgical effect." and "maximum power for ball when used in coag setting is 30 watts.Exceeding maximum power settings may result in patient injury or product damage." as the device was used at settings much higher than the insgructions indicate, the root cause is user error.This should be considered the final report.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: Medtronic Covidien 5mm Ball.
• Common Device Name: Ball Electrode
• Manufacturer (Section D): Aspen Surgical Products, Inc.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; +1(616)698-7100
• MDR Report Key: 50481041
• Report Number: 3002750084-2026-00093
• Device Sequence Number: 13305369
• Product Code: HGI
• UDI-Device Identifier: 10887482196653
• UDI-Public: 10887482196653
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: E1564
• Device Lot Number: X0625ZX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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