FDA Adverse Event
Other
Summary report: N
NEPTUNE SAFE AIR SMOKE EVACUATION PENCIL
MDR report key: 23760330
·
Received December 9, 2025
Report
- Report Number
- 23760330
- Event Type
- Other
- Date Received
- December 9, 2025
- Date of Event
- November 21, 2025
- Report Date
- December 5, 2025
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- GEI
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
BOVIE PENCIL ACTIVATED ON IT'S ON DURING A SURGICAL PROCEDURE. WHEN THE OPERATING ROOM TEAM HEARD THE ACTIVATION SOUND, THEY LOOKED AT THE PENCIL. NO ONE TOUCHED THE PENCIL TO ACTIVATE. BURN NOTICED ON UPPER ABDOMEN. REMOVED EQUIPMENT FROM OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2885256 | NEPTUNE SAFE AIR SMOKE EVACUATION PENCIL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER ENDOSCOPY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |