MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for RADIAL JAW M00515190 manufactured by Boston Scientific.
[44930644]
Patient Sequence No: 1, Text Type: N, H10
[44930725]
Final biopsy with needle forceps being performed. Physician being assisted by rrt with opening and closing of the forceps. Previous biopsies were uneventful. It appeared that a minute fragment or single tooth of the forceps separated off the main forceps and was in the patient's airway. Another pulmonologist was called for assistance and the fragment was removed with the help of a rat-tooth forceps. However, the fragment was not visualized with the naked eye upon removal. It was likely covered with blood/fibrin and hence difficult to see. Subsequent airway survey did not reveal any foreign body. Stat x-ray of the chest performed which revealed no metallic foreign body in the lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5646289 |
| MDR Report Key | 5646289 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-03-09 |
| Report Date | 2016-03-01 |
| Date Reported to FDA | 2016-03-01 |
| Date Reported to Mfgr | 2016-03-01 |
| Date Added to Maude | 2016-05-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | RADIAL JAW |
| Generic Name | FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BWH |
| Date Received | 2016-05-11 |
| Catalog Number | M00515190 |
| Lot Number | 18087127 |
| ID Number | 90402821-06 |
| Device Expiration Date | 2018-06-25 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-11 |