MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. GROUNDING PLATE A1200

Model Number	A1204P
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is in process of being returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we purchased a brand new bovie for mfi medical.The grounding plate had caused a burn in one patient.".
Additional Manufacturer Narrative
The device was returned for evaluation, and it functioned well and tested to specifications.The root cause is undetermined.The most likely root cause is user error, due to the current concentrating in one location as this can be caused by insufficient contact with the patient.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: GROUNDING PLATE A1200
• Common Device Name: GROUNDING PLATE
• 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 ; 6166987100
• MDR Report Key: 25306452
• Report Number: 3002750084-2026-00051
• Device Sequence Number: 9517694
• Product Code: GEI
• UDI-Device Identifier: 00887482176948
• UDI-Public: 00887482176948
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: A1204P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown