MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for RADIAL JAW 4 manufactured by Boston Scientific Corporation.
[146216564]
Patient was undergoing a bronchoscopy related to a right middle lobe cavitary lesion. The biopsy forceps being used for the procedure malfunctioned and would not close after an attempted biopsy. The device malfunction resulted in a piece of the forceps lodged in the patient's lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8645204 |
| MDR Report Key | 8645204 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-05-07 |
| Report Date | 2019-05-17 |
| Date Reported to FDA | 2019-05-17 |
| Date Reported to Mfgr | 2019-05-28 |
| Date Added to Maude | 2019-05-28 |
| 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 | 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 | 3 |
| Brand Name | RADIAL JAW 4 |
| Generic Name | FORCEPS, BIOPSY, BRONCHOSCOPE |
| Product Code | BWH |
| Date Received | 2019-05-28 |
| Lot Number | 22687804 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 017521234 US 017521234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-28 |