FDA Adverse Event
Malfunction
Summary report: N
MINERVA SINGLE STERILE DISPOSABLE HANDPIECE
MDR report key: 24953015
·
Received April 22, 2026
Report
- Report Number
- 24953015
- Event Type
- Malfunction
- Date Received
- April 22, 2026
- Date of Event
- February 25, 2026
- Report Date
- April 9, 2026
- Manufacturer
- MINERVA SURGICAL, INC.
- Product Code
- MNB
- UDI-DI
- 00862393000162
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MINERVA HANDPIECE ERROR CODE 002 OCCURRED WITH 59 SECONDS REMAINING OUT OF 120 SECOND BURN TIME. REPLACED WITH NEW HANDPIECE. LOT 25F09-04 REF: MIN9770 EXP: 06/09/2027.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1010381 | MINERVA SINGLE STERILE DISPOSABLE HANDPIECE | DEVICE, THERMAL ABLATION, ENDOMETRIAL | MNB | MINERVA SURGICAL, INC. | MIN9770 | 25F09-041727 | 00862393000162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |