MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-04 for ??SHOCKPUL SE?LITHOTRIPSY?PROBE, STERILE?SINGLE?USE,?3.76MM?(3/BOX) ??SPL-PD376 manufactured by Cybersonics Inc..
[110181268]
The pouch of the subject device is requested from the customer. Following additional information is shared by the customer: "one person carried the box into the operating room and pulled out one probe from the box and discovered it was open at the top by the peel area. The other 2 were inspected from the box and were intact. No pictures are available right now. " ifu instructs to inspect the product/package for any damage. "do not use if package is damaged" symbol is on label of the product and also in the ifu. If significant additional information is received, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[110181269]
"spl-pd376 sterile packaging was open upon opening outer box. No patient involvement. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004216443-2018-00001 |
| MDR Report Key | 7564805 |
| Date Received | 2018-06-04 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-05-16 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2018-02-05 |
| Date Added to Maude | 2018-06-04 |
| 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 | 0 |
| Brand Name | ??SHOCKPUL SE?LITHOTRIPSY?PROBE, STERILE?SINGLE?USE,?3.76MM?(3/BOX) |
| Generic Name | ELECTROHYDRAULIC LITHOTRIPTOR |
| Product Code | FEO |
| Date Received | 2018-06-04 |
| Model Number | ??SPL-PD376 |
| Lot Number | D1800854 |
| 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 | 2018-06-04 |