FDA Adverse Event
Summary report: N
KERRISON 1 MM GOLD TIP RONGEUR
MDR report key: 14680
·
Received July 14, 1994
Report
- Report Number
- MW1002819
- Date Received
- July 14, 1994
- Date of Event
- May 7, 1994
- Report Date
- June 29, 1994
- Manufacturer
- AESCULAP INSTRUMENTS CORP.
- Product Code
- HTX
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING SURGICAL PROCEDURE TIP WAS DISCOVERED TO BE MISSING OFF RONGEUR. POSSIBLE RETENTION OF MISSING PIECE (NOT FOUND DURING SURGERY). X-RAY SHOWS FOREIGN BODY BUT UNABLE TO DETERMINE WHETHER MISSING PIECE OR SURGICAL CLIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KERRISON 1 MM GOLD TIP RONGEUR | RONGEUR | HTX | AESCULAP INSTRUMENTS CORP. | FF771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |