MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for GENESYS HTA PROCERVA PROCEDURE SET M006580210 manufactured by Boston Scientific Corporation.
[181774851]
Upon insertion of the hta procerva device, the system malfunctioned and an error message displayed on the machine. The machine read error 10.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093348 |
| MDR Report Key | 9764045 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-14 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| 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 | GENESYS HTA PROCERVA PROCEDURE SET |
| Generic Name | DEVICE, THERMAL ABLATION, ENDOMETRAL |
| Product Code | MNB |
| Date Received | 2020-02-26 |
| Catalog Number | M006580210 |
| Lot Number | 24250468 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |