MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-10-29 for SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.40MM SPL-PR340 manufactured by Cybersonics Inc..
[125350598]
The device was not returned to cybersonics for evaluation. The event occurred during reuse of the device. Instructions for use (ifu) of the device recommends 5 reuses. It is not clear how many times the device has been reused. A review of similar reported complaints indicates that this reported phenomenon is likely attributed to excessive force applied on the device, excessive use of the device and/ or excessive bending during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[125350599]
The doctor was performing percutaneous nephrolithotomy procedure (pcnl) and during the procedure, probe broke. The doctor removed the probe from the patient and continued the surgery using another probe. No injury or health hazard was reported to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004216443-2018-00004 |
| MDR Report Key | 8015458 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2016-11-14 |
| Date Added to Maude | 2018-10-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SAMRADNI PATIL |
| Manufacturer Street | 5340 FRYLING ROAD SUITE 101 |
| Manufacturer City | ERIE PA 165104703 |
| Manufacturer Country | US |
| Manufacturer Postal | 165104703 |
| Manufacturer Phone | 8149201510 |
| Manufacturer G1 | CYBERSONICS INC. |
| Manufacturer Street | 5340 FRYLING ROAD SUITE 101 |
| Manufacturer City | ERIE PA 165104703 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 165104703 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOCKPULSE SE LITHOTRIPSY PROBE, REUSABLE, 3.40MM |
| Generic Name | ELECTROHYDRAULIC LITHOTRIPTOR. |
| Product Code | FEO |
| Date Received | 2018-10-29 |
| Model Number | SPL-PR340 |
| Lot Number | W1606167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERSONICS INC. |
| Manufacturer Address | 5340 FRYLING ROAD SUITE 101 ERIE PA 165104703 US 165104703 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |