FDA Adverse Event
Malfunction
Summary report: N
ROTATABLE OSTIUM PUNCH
MDR report key: 275127
·
Received April 20, 2000
Report
- Report Number
- 1418479-2000-00022
- Event Type
- Malfunction
- Date Received
- April 20, 2000
- Date of Event
- March 20, 2000
- Report Date
- March 24, 2000
- Manufacturer
- RICHARD WOLF GMBH
- Product Code
- KTF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A SINUS SURGERY WAS IN PROGRESS WHEN A PIECE OF THE OSTIUM PUNCH BROKE OFF IN THE NASAL CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROTATABLE OSTIUM PUNCH | OSTIUM PUNCH | KTF | RICHARD WOLF GMBH | 8211.661 | P660472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |