FDA Adverse Event
Malfunction
Summary report: N
TAKAHASHI NASAL FORCEPS
MDR report key: 2550902
·
Received April 19, 2012
Report
- Report Number
- 2550902
- Event Type
- Malfunction
- Date Received
- April 19, 2012
- Date of Event
- April 12, 2012
- Report Date
- April 19, 2012
- Manufacturer
- STORZ INSTRUMENTS
- Product Code
- JXX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- KY, US
Narratives
Description of Event or Problem · 1
PATIENT WAS UNDERGOING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY AND SEPTOPLASTY. PHYSICIAN WAS USING TAKAHASHI FORCEPS. HE HAD THE FORCEPS IN THE NOSE, PREPARING TO REMOVE SOME TISSUE, WHEN THE TOP OF THE BLADE BROKE OFF IN THE NOSE. PIECES WERE REMOVED AND THERE WAS NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAKAHASHI NASAL FORCEPS | FORCEPS, NASAL | JXX | STORZ INSTRUMENTS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |