MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-09-14 for SHOCKPULSE SE LITHOTRIPSY PROBE, STERILE SINGLE USE, 3.76MM (3/BOX) SPL-PDBX376 manufactured by Cybersonics Inc..
[120258927]
The device was not returned to cybersonic for evaluation. A review of similar reported complaints indicate that this reported phenomenon is likely attributed to excessive force applied on the device and/ or excessive torqing during the procedure. It is not clear how the additional hole was caused practically.
Patient Sequence No: 1, Text Type: N, H10
[120258928]
The user facility reported that during a lithotripsy procedure the lithotripsy probe broke off six inches from the seating thread. An extra hole was made in an attempt to locate the broken piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004216443-2018-00002 |
| MDR Report Key | 7876514 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-17 |
| Date Mfgr Received | 2018-08-21 |
| Device Manufacturer Date | 2017-12-26 |
| Date Added to Maude | 2018-09-14 |
| 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 | 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 (3/BOX) |
| Generic Name | ELECTROHYDRAULIC LITHOTRIPTOR, PRODUCT CODE: FEO |
| Product Code | FEO |
| Date Received | 2018-09-14 |
| Model Number | SPL-PDBX376 |
| Lot Number | D1700851 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-09-14 |