MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for MINERVA SINGLE STERILE DISPOSABLE HANDPIECE MIN9770 manufactured by Minerva Surgical, Inc..
[182735381]
The device failed to fire. No patient harm. Another device obtained. Procedure continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9811084 |
| MDR Report Key | 9811084 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-01-23 |
| Date of Event | 2018-11-22 |
| Report Date | 2020-01-23 |
| Date Reported to FDA | 2020-01-23 |
| Date Reported to Mfgr | 2020-03-10 |
| Date Added to Maude | 2020-03-10 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | MINERVA SINGLE STERILE DISPOSABLE HANDPIECE |
| Generic Name | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
| Product Code | MNB |
| Date Received | 2020-03-10 |
| Model Number | MIN9770 |
| Catalog Number | MIN9770 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINERVA SURGICAL, INC. |
| Manufacturer Address | 101 SAGINAW DRIVE REDWOOD CITY CA 94063 US 94063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |