MAUDE Adverse Event Report: MEDLINE - MEXICALI MEDLINE; MINOR GENERAL PACK

Catalog Number	DYNJ44494C
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon wanted to use the coag function on the bovie pencil and it did not work.Bovie was switched from monopolar 2 to monopolar 1 to see if the machine was the problem, but the coag function still did not work.Cut function did work, however.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Cautery not working.

• Brand Name: MEDLINE
• Common Device Name: MINOR GENERAL PACK
• Manufacturer (Section D): MEDLINE - MEXICALI; calle circuito del desierto 71; mexicali; baja california, 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24952936
• Report Number: 1423395-2026-00093
• Device Sequence Number: 5278386
• Product Code: FDE
• UDI-Device Identifier: 10198459241901
• UDI-Public: 10198459241901
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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 Catalogue Number: DYNJ44494C
• Device Lot Number: 25KMJ765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• 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