MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-01 for RADIAL JAW 4 * 1333 manufactured by Boston Scientific.
[18509631]
Per physician, the biopsy forceps end did not correctly open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2495525 |
| MDR Report Key | 2495525 |
| Date Received | 2012-03-01 |
| Date of Report | 2012-03-01 |
| Date of Event | 2012-02-27 |
| Report Date | 2012-03-01 |
| Date Reported to FDA | 2012-03-01 |
| Date Added to Maude | 2012-03-19 |
| 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 | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 4 |
| Generic Name | FORCEPS, BIOPSY |
| Product Code | BWH |
| Date Received | 2012-03-01 |
| Returned To Mfg | 2012-03-01 |
| Model Number | * |
| Catalog Number | 1333 |
| Lot Number | 14841774 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760153 US 01760 1537 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-01 |