MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-11 for OLYMPUS OLYMPUS ENF TYPE P3 * manufactured by Olympus America, Inc..
[20511932]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 528598 |
| MDR Report Key | 528598 |
| Date Received | 2004-05-11 |
| Date of Report | 2004-04-01 |
| Date of Event | 2004-03-01 |
| Date Added to Maude | 2004-06-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | RHINO-LARYNGOFIBERSCOPE |
| Product Code | EQN |
| Date Received | 2004-05-11 |
| Model Number | OLYMPUS ENF TYPE P3 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 517788 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | 2 CORPORATE CENTER DRIVE MELVILLE NY 11747 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-11 |