MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-20 for OLYMPUS FB - 19C manufactured by Olympus.
[22185215]
During bronchoscopy tissue was being retrieved for patholgy. After tissue grasped with forceps, the forceps broke off. Damaged forcep was retrieved using a second forcep without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16932 |
| MDR Report Key | 16932 |
| Date Received | 1994-01-20 |
| Date of Report | 1993-12-01 |
| Date of Event | 1993-11-19 |
| Date Facility Aware | 1993-11-19 |
| Report Date | 1993-12-01 |
| Date Reported to Mfgr | 1993-12-01 |
| Date Added to Maude | 1994-10-19 |
| 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 | 0 |
| 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 | BIOPSY FORCEP |
| Product Code | BWH |
| Date Received | 1994-01-20 |
| Model Number | FB - 19C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16865 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | 8370 DOW CIRCLE STRONGSVILLE OH 44136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-01-20 |