MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-31 for CYBERWAND SPL-PD376 manufactured by Olympus.
[58974500]
Percutaneous nephrolithotomy with cyberwand/shock pulse probe shed small flakes of metal into the pt's kidney.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065743 |
| MDR Report Key | 6072068 |
| Date Received | 2016-10-31 |
| Date of Report | 2016-10-31 |
| Date of Event | 2016-10-28 |
| Date Added to Maude | 2016-11-02 |
| 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 | 3 |
| Brand Name | CYBERWAND |
| Generic Name | SHOCK PULSE PROBE |
| Product Code | FEO |
| Date Received | 2016-10-31 |
| Model Number | SPL-PD376 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-31 |