MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for RADIAL JAW 4 M00513370 manufactured by Boston Scientific Corporation.
[173931149]
Upon polyp removal, forceps were noted to be damaged. Forceps withdrawn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9557425 |
| MDR Report Key | 9557425 |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-21 |
| Date of Event | 2019-10-21 |
| Report Date | 2019-12-21 |
| Date Reported to FDA | 2019-12-21 |
| Date Reported to Mfgr | 2020-01-07 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 4 |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC |
| Product Code | FCL |
| Date Received | 2020-01-07 |
| Model Number | M00513370 |
| Catalog Number | M00513370 |
| Lot Number | 20047247 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |