MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-05-24 for OLYMPUS FB-19C-1 NA manufactured by Olympus Optical Co. Ltd..
[19162828]
A medical center respiratory therapist reported that reusable biopsy forceps wires broke during three different bronchoscopy procedures as the physician was attempting to take biopsies (of lung mass). Procedures were completed with different forceps. There were no complications related to the occurrences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2000-00031 |
| MDR Report Key | 279850 |
| Report Source | 07 |
| Date Received | 2000-05-24 |
| Date of Report | 2000-05-02 |
| Date Mfgr Received | 2000-05-02 |
| Date Added to Maude | 2000-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2 CORPORATE CENTER DR |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5168445688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | FENESTRATED BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 2000-05-24 |
| Model Number | FB-19C-1 |
| Catalog Number | NA |
| Lot Number | K8Z07 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 270830 |
| Manufacturer | OLYMPUS OPTICAL CO. LTD. |
| Manufacturer Address | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME TOKYO JA 163-91 |
| Baseline Brand Name | OLYMPUS |
| Baseline Generic Name | FENESTRATED BIOPSY FORCEPS |
| Baseline Model No | FB-19C-1 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955065 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-05-24 |