MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for ION FLEXISION BIOPSY NEEDLE 21 G manufactured by Intuitive Surgical, Inc..
[182544945]
Ion flexision biopsy needle 21 g used during a robotics navigational bronchoscopy and biopsy. After sample put into specimen container, needle did not retract but stayed extended. No harm to pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093545 |
| MDR Report Key | 9799380 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-28 |
| Date Added to Maude | 2020-03-06 |
| 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 | 3 |
| Brand Name | ION FLEXISION BIOPSY NEEDLE 21 G |
| Generic Name | BRONCHOSCOPE (FLEXIBLE RIGID) |
| Product Code | EOQ |
| Date Received | 2020-03-05 |
| Lot Number | S90190923 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-05 |