MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-01 for ALLIGATOR BX FORCEPS FB-211D manufactured by Olympus - Roswell.
[74425390]
Bronchial forceps model #fb-211d failed to open after being applied to endobronchial stent in an attempt to remove stent in airway. After removing forceps from airway, forceps would not open or close.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069529 |
| MDR Report Key | 6541109 |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-04-12 |
| Date Added to Maude | 2017-05-03 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALLIGATOR BX FORCEPS |
| Generic Name | FORCEPS, BIOPSY |
| Product Code | NWW |
| Date Received | 2017-05-01 |
| Model Number | FB-211D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS - ROSWELL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-01 |