FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 133545
·
Received November 20, 1997
Report
- Report Number
- MW1012490
- Event Type
- Malfunction
- Date Received
- November 20, 1997
- Date of Event
- November 6, 1997
- Report Date
- November 14, 1997
- Manufacturer
- OLYMPUS AMERICA, INC.
- Product Code
- EOQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
O RING ON THE END OF INTUBATION BRONCHOSCOPY LFI BROKE OFF IN THE PT'S BRONCHI WHILE CHECKING PLACEMENT OF DOUBLE LUMEN ET TUBE. AN ADULT BRONCHOSCOPE AND BRONCHOSCOPY FORCEPS WERE USED TO RETRIEVE THE FOREIGN BODY. NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | EOQ | OLYMPUS AMERICA, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |