MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for LITHOCLAS M0068407160 manufactured by Boston Scientific.
[101771470]
Patient Sequence No: 1, Text Type: N, H10
[101771471]
Probe is supposed to be replaced after 5 uses. Was only used 2-3x in past 2 years but it broke in half while in nephroscope sheath/ in patient. Removed from patient and continued procedure with lithoclast component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7319908 |
| MDR Report Key | 7319908 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-03-02 |
| Date of Event | 2017-11-07 |
| Report Date | 2017-12-05 |
| Date Reported to FDA | 2017-12-05 |
| Date Reported to Mfgr | 2017-12-05 |
| Date Added to Maude | 2018-03-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | LITHOCLAS |
| Generic Name | LITHROTRIPTOR PROBE |
| Product Code | FFK |
| Date Received | 2018-03-07 |
| Model Number | M0068407160 |
| Catalog Number | M0068407160 |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-07 |