MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-27 for SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE, SINGLE USE, 3.76MM SPL-PD376 manufactured by Cybersonics Inc..
[128418927]
The device was not returned to cybersonics for evaluation. A review of similar reported complaints indicates that this reported phenomenon is likely attributed to excessive force applied on the device, and/ or excessive bending during the procedure.
Patient Sequence No: 1, Text Type: N, H10
[128418928]
Shockpulse lithotripsy probe broke inside the patient. Broken piece is retrieved from the patient. No injury or health hazard was reported to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004216443-2018-00006 |
| MDR Report Key | 8106152 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2017-10-17 |
| Date Added to Maude | 2018-11-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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, STERILE, SINGLE USE, 3.76MM |
| Generic Name | ELECTROHYDRAULIC LITHOTRIPTOR. |
| Product Code | FEO |
| Date Received | 2018-11-27 |
| Model Number | SPL-PD376 |
| Lot Number | D1707047 |
| 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 | 2018-11-27 |