MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-27 for ASPIRATION NEEDLE FOR FIBEROPTIC BRONCHOSCOPY MD-84 manufactured by Olympus America, Inc..
[16480255]
Biopsy needle separated from guide wire on 4 aspiration needle sets. This could result in the needle being lost in the pt's airway during a bronchoscopic procedure. All 4 items were from the same lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004566 |
| MDR Report Key | 18538 |
| Date Received | 1994-12-27 |
| Date Added to Maude | 1994-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPIRATION NEEDLE FOR FIBEROPTIC BRONCHOSCOPY |
| Generic Name | ASPIRATION NEEDLE |
| Product Code | KTR |
| Date Received | 1994-12-27 |
| Returned To Mfg | 1994-12-13 |
| Catalog Number | MD-84 |
| Lot Number | 46R |
| ID Number | 702394 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18466 |
| Manufacturer | OLYMPUS AMERICA, INC. |
| Manufacturer Address | LAKE SUCCESS NY 110421197 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-12-27 |