MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-01 for OLYMPUS FB-15C-1 * manufactured by Olymus.
[339303]
Trans bronchial biopsy x4 done under general anesthesia. On the fourth biopsy, the cable to the forceps broke with displacement of the forceps head, unable to close. Both the forceps and the bronchoscopy scope were removed/withdrawn with one movement. Post removal, pt, with significant bleeding over 100cc blood loss. Multiple clots removed via bronchoscope. Pt required transfer to the icu and remained on ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 547114 |
| MDR Report Key | 547114 |
| Date Received | 2004-10-01 |
| Date of Report | 2004-09-23 |
| Date of Event | 2004-09-23 |
| Date Facility Aware | 2004-09-23 |
| Date Added to Maude | 2004-10-06 |
| 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 | BRONCH BIOPSY FORCEP |
| Product Code | BWH |
| Date Received | 2004-10-01 |
| Model Number | FB-15C-1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 536525 |
| Manufacturer | OLYMUS |
| Manufacturer Address | TWO CORPORUTE CENTER DR MELVILLE NY 117473157 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2004-10-01 |