MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-09 for BIOPSY FORCEPS FB-19C manufactured by Olympus Corp..
[21393803]
Finger control broke. Physician had to manually close and remove forceps from pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003294 |
| MDR Report Key | 15991 |
| Date Received | 1994-09-08 |
| Date of Report | 1994-08-24 |
| Date of Event | 1994-08-16 |
| Date Added to Maude | 1994-09-12 |
| 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 |
| 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 | BIOPSY FORCEPS |
| Generic Name | BIOPSY FORCEPS |
| Product Code | BWH |
| Date Received | 1994-09-09 |
| Catalog Number | FB-19C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15924 |
| Manufacturer | OLYMPUS CORP. |
| Manufacturer Address | LAKE SUCCESS NY 110421176 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-08 |