MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE M0068402910 manufactured by Boston Scientific Corp..
[142196393]
While in use per manufacturer's instructions, the boston scientific swiss lithoclast trilogy disposable probe broke in half during use. Probe broke (cleanly) while within the nephroscope and was immediately recovered and removed from the field. Company representative (b)(4) present. Fda safety report id (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085865 |
| MDR Report Key | 8515271 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-10 |
| Date Added to Maude | 2019-04-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2019-04-12 |
| Model Number | M0068402910 |
| Catalog Number | M0068402910 |
| Lot Number | 166562A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Brand Name | SWISS LITHOCLAST TRILOGY DISPOSABLE PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2019-04-12 |
| Model Number | M0068402910 |
| Catalog Number | M0068402910 |
| Lot Number | 166557A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |