MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for ULTRASOUND PROBE M0068407170 manufactured by Boston Scientific Corporation.
[139999378]
During percutaneous nephrolithomy case, md was using ultrasound lithotripsy to break up kidney stones. The ultrasound probe used to operate the lithotripsy within the nephroscope broke in half midway through the procedure. The broken piece was removed from the sterile field, and a new ultrasound probe was given to md.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8455209 |
| MDR Report Key | 8455209 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-03-08 |
| Report Date | 2019-03-11 |
| Date Reported to FDA | 2019-03-11 |
| Date Reported to Mfgr | 2019-03-27 |
| Date Added to Maude | 2019-03-27 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASOUND PROBE |
| Generic Name | LITHOTRIPTOR, ELECTRO-HYDRAULIC |
| Product Code | FFK |
| Date Received | 2019-03-27 |
| Model Number | M0068407170 |
| Catalog Number | M0068407170 |
| Lot Number | 23023809 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-27 |