MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-27 for RADIAL JAW 3 * M00515231 manufactured by Boston Scientific.
[2747824]
During the procedure it was noted that the jaws of the forceps were sprung while removing a specimen from the device. All parts of the device were present, but the jaws would not close.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2559528 |
| MDR Report Key | 2559528 |
| Date Received | 2012-04-27 |
| Date of Report | 2012-04-27 |
| Date of Event | 2012-03-23 |
| Report Date | 2012-04-27 |
| Date Reported to FDA | 2012-04-27 |
| Date Added to Maude | 2012-05-04 |
| 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 3 |
| Generic Name | FORCEPS, BIOPSY |
| Product Code | BWH |
| Date Received | 2012-04-27 |
| Model Number | * |
| Catalog Number | M00515231 |
| Lot Number | 14819365 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-27 |