FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR ELECTRODE / VAPORIZATION (SIDE LOAD; ROUND FITTING ; FR26)
MDR report key: 24413523
·
Received February 23, 2026
Report
- Report Number
- 24413523
- Event Type
- Malfunction
- Date Received
- February 23, 2026
- Date of Event
- February 12, 2026
- Report Date
- February 17, 2026
- Manufacturer
- LAMIDEY NOURY MEDICAL
- Product Code
- GEI
- UDI-DI
- 03665415002253
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- DE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473087 | BIPOLAR ELECTRODE / VAPORIZATION (SIDE LOAD; ROUND FITTING ; FR26) | ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES | GEI | LAMIDEY NOURY MEDICAL | MVVS | 2527-2 | 03665415002253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |