FDA Adverse Event
Injury
Summary report: N
OLYMPUS 24FRENCH
MDR report key: 1990016
·
Received February 9, 2011
Report
- Report Number
- MW5019384
- Event Type
- Injury
- Date Received
- February 9, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 9, 2011
- Manufacturer
- NA
- Product Code
- FAJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CERAMIC TIP OF OLYMPUS TRANSURETHRAL SHEATH BROKE OFF. A 24FR, A2204A, CRUSHED BY SURGEON INTENTIONALLY & FLUSHED WITH IRRIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS 24FRENCH | A2204A | FAJ | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |