MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for SWISS LITHOCLAST SELECT manufactured by Boston Scientific Corporation.
[35011124]
Patient Sequence No: 1, Text Type: N, H10
[35011145]
The pt had a very large stone; physician using both pneumatic/lithoclast during percutaneous nephrolithotomy, metal shavings were breaking off of the probe. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5343078 |
| MDR Report Key | 5343078 |
| Date Received | 2016-01-05 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-08-14 |
| Report Date | 2015-11-12 |
| Date Reported to FDA | 2015-11-12 |
| Date Reported to Mfgr | 2015-11-12 |
| Date Added to Maude | 2016-01-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | SWISS LITHOCLAST SELECT |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2016-01-05 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-05 |