FDA Adverse Event
Injury
Summary report: N
SMOKE EVACUATION PENCIL
MDR report key: 24033968
·
Received January 12, 2026
Report
- Report Number
- MW5182024
- Event Type
- Injury
- Date Received
- January 12, 2026
- Date of Event
- January 5, 2026
- Report Date
- January 5, 2026
- Manufacturer
- MEDTRONIC DISTRIBUTION CENTER
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SMOKE EVACUATION PENCIL NOT WORKING REF: 0703-046-000, LOT: 2509001, EXP: 02-24-2028.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107781 | SMOKE EVACUATION PENCIL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MEDTRONIC DISTRIBUTION CENTER | 2509001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Required Intervention |