FDA Adverse Event
Other
Summary report: N
OLYMPUS
MDR report key: 528598
·
Received May 11, 2004
Report
- Report Number
- 528598
- Event Type
- Other
- Date Received
- May 11, 2004
- Date of Event
- March 1, 2004
- Report Date
- April 1, 2004
- Manufacturer
- OLYMPUS AMERICA, INC.
- Product Code
- EQN
- Report Source
- User Facility report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE SCOPE WAS USED TO VISUALIZE A PATIENT'S NASO-PHARYNGEAL CANCER. THE SCOPE WAS PLACED INTO THE ANTERIOR NARES. AFTER ITS USE IT WAS NOTED THAT ~2.5 CENTIMETER OF THE DISTAL COATING WAS MISSING. AFTER DISCUSSIONS WITH THE PHYSICIAN STAFF, IT WAS DISCOVERED THAT DURING THE PRIOR USE, THERE HAD BEEN SOME DIFFICULTY IN REMOVING THE SHEATH POST THE PROCEDURE AND THE PHYSICIAN USED SCISSORS TO CUT THE SHEATH, THUS CUTTING THE SCOPE'S COATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | RHINO-LARYNGOFIBERSCOPE | EQN | OLYMPUS AMERICA, INC. | OLYMPUS ENF TYPE P3 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other | SLIDE-ON ENDOSHEATH. |