MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-08 for OLYMPUS CYBERWAND ULTRASONIC LITHOTRIPTER PROBE CW-USLTA manufactured by Olympus.
[102191222]
Md getting ready to do pcnl procedure and testing the transducer prior to the procedure observed sparks coming from the transducer cord and the test was not able to complete. Cord completely burned off transducer at the area where the electric black cord and transducer meet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075780 |
| MDR Report Key | 7327199 |
| Date Received | 2018-03-08 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-02-23 |
| Date Added to Maude | 2018-03-09 |
| 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 | OLYMPUS CYBERWAND ULTRASONIC LITHOTRIPTER PROBE |
| Generic Name | LITHOTRIPTOR, ULTRASONIC |
| Product Code | FEO |
| Date Received | 2018-03-08 |
| Model Number | CW-USLTA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-08 |