MAUDE Adverse Event Report: LAMIDEY NOURY MEDICAL BIPOLAR ELECTRODE / VAPORIZATION (SIDE LOAD; ROUND FITTING ; FR26); ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	MVVS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Bipolar electrode was being used, and an error code appeared on the bipolar machine.We then turned the machine off and unplugged the electrode and retried it.The error code reappeared and we obtained a new bipolar electrode and turned the machine off and on again.After getting a new electrode, the machine was working fine.The faulty bipolar will be given to materials with the file number attached.

• Brand Name: BIPOLAR ELECTRODE / VAPORIZATION (SIDE LOAD; ROUND FITTING ; FR26)
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): LAMIDEY NOURY MEDICAL; 3020 nw 82nd avenue; miami doral FL 33122
• MDR Report Key: 24413523
• Report Number: 24413523
• Device Sequence Number: 10577496
• Product Code: GEI
• UDI-Device Identifier: 03665415002253
• UDI-Public: (01)03665415002253
• 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): 02/17/2026
• Report Date (Section F): 02/17/2026

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: MVVS
• Device Catalogue Number: MVVS
• Device Lot Number: 2527-2
• 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: 02/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/17/2026