MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-07-18 for OLYMPUS FB-19C-1 NA manufactured by Olympus Optical Co. Ltd..
[228322]
A hospital nurse reported that a cup from a reusable forceps broke off and fell into a patient during a bronchoscopy procedure. The piece was successfully retrieved and there were no complications associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2001-00050 |
| MDR Report Key | 342952 |
| Report Source | 07 |
| Date Received | 2001-07-18 |
| Date of Report | 2001-06-19 |
| Date Mfgr Received | 2001-06-19 |
| Date Added to Maude | 2001-07-24 |
| 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 |
| 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 DRIVE |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 6318445688 |
| 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 | 2001-07-18 |
| Model Number | FB-19C-1 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 332288 |
| 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 | 2001-07-18 |