MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for CYBERWAND PROBE CW-RBP manufactured by Cybersonics Inc..
[96209653]
After the completion of the cyberwand lithotripsy, cmtee davenport st was disassembling cyberwand and noticed a screen was broken. No harm to patient. Dr. (b)(6). Dates of use: (b)(6) 2017 1510-17:15. Diagnosis or reason for use: left kidney stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074284 |
| MDR Report Key | 7154367 |
| Date Received | 2017-12-28 |
| Date of Report | 2017-12-26 |
| Date of Event | 2017-11-29 |
| Date Added to Maude | 2017-12-29 |
| 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 |
| 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 | CYBERWAND PROBE |
| Generic Name | CYBERWAND PROBE |
| Product Code | FFK |
| Date Received | 2017-12-28 |
| Model Number | CW-RBP |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERSONICS INC. |
| Manufacturer Address | 5340 FRYING RD., STE 101 KNOWLEDGE PARK ERIE PA 16510 US 16510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-28 |