FDA Adverse Event
Injury
Summary report: N
ELECTRIC SCALPEL
MDR report key: 22914042
·
Received August 28, 2025
Report
- Report Number
- MW5175335
- Event Type
- Injury
- Date Received
- August 28, 2025
- Date of Event
- August 20, 2025
- Report Date
- September 5, 2025
- Manufacturer
- VONCARE MEDICAL DEVICE CO. LTD.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 9/5/25 FOR REPORT MW5175335 TO UPDATE PROCODE.
Description of Event or Problem · 0
IT WAS REPORTED THAT, DURING TONSILLECTOMY, THE NURSE ANESTHETIST WARNED THE ENT (EARS, NOSE AND THROAT) SURGEON THAT THERE WAS A LEAK IN THE BREATHING TUBE. THEY PLANNED TO RE-INTUBATE THE PATIENT AFTER CAUTERIZATION OF THE FIRST TONSIL WHEN SUDDENLY WITH THE USE OF THE (B)(6) ELECTRIC SCALPEL THE ORAL CAVITY CATCHES FIRE. THE LEAD WAS REMOVED AND PATIENT WAS RE-INTUBATED IMMEDIATELY. THE ORAL CAVITY WAS BURNED AND UNEXPLORED CONSEQUENCES ON THE TRACHEA AND LUNGS. THE HOSPITALIZATION WAS EXTENDED AND THE PATIENT WAS ADMITTED TO THE ICU (INTENSIVE CARE UNIT). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1698350 | ELECTRIC SCALPEL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | VONCARE MEDICAL DEVICE CO. LTD. | VT 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female |