MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-15 for RADIAL JAW * manufactured by Boston Scientific Corporation.
[4975485]
During proximal esophageal biopsy, radial jaw forcep (lot #16995416) (boston scientific) a piece of metal came off during biopsy and was visible in the esophagus. Piece of metal was able to be removed with the forcep and no visible injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4216694 |
| MDR Report Key | 4216694 |
| Date Received | 2014-10-15 |
| Date of Report | 2014-10-15 |
| Date of Event | 2014-09-05 |
| Report Date | 2014-10-15 |
| Date Reported to FDA | 2014-10-15 |
| Date Reported to Mfgr | 2014-10-31 |
| Date Added to Maude | 2014-10-31 |
| 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 | RADIAL JAW |
| Generic Name | FORCEPS |
| Product Code | BWH |
| Date Received | 2014-10-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 16995416 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-15 |