MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for RADIAL JAW 4 BIOPSY FORCEPS manufactured by Boston Scientific.
[69142528]
Radial jaw 4 biopsy forceps not working properly. When the forceps are closed and reopened, the spike becomes hidden on one side of the forceps. Mfr: please note that we do no send products to the mfr, but you may arrange for pick-up by calling my number below.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068222 |
| MDR Report Key | 6375786 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-02-21 |
| Date of Event | 2016-12-22 |
| Date Added to Maude | 2017-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | RADIAL JAW 4 BIOPSY FORCEPS |
| Generic Name | BRONCHOSCOPE AND ACCESSORIES |
| Product Code | BWH |
| Date Received | 2017-03-01 |
| Lot Number | 19630257 |
| Device Expiration Date | 2019-08-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-01 |