MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-07 for MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM MIN9770 manufactured by Minerva Surgical, Inc..
[178201990]
The device used in this case was not returned. A device history record review was conducted for the handpiece in question. The handpiece was released meeting all qa specifications. Uterine perforations are known complications of endometrial ablation. Complications associated with uterine perforations are addressed in the warning section of the minerva endometrial ablation system operator's manual and instructions for use, including the statements: use caution not to perforate the uterine wall when sounding, dilating or inserting the minerva disposable handpiece. Excessive force applied during placement of the minerva disposable handpiece may result in tissue injury including perforation.
Patient Sequence No: 1, Text Type: N, H10
[178201991]
During a minerva procedure a uterine perforation was detected by the minerva uterine integrity test before any energy application. The case was appropriately aborted. The perforation was confirmed and cauterized laparoscopically.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011011193-2020-00003 |
| MDR Report Key | 9682519 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-05-16 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELSIE WELLS |
| Manufacturer Street | 101 SAGINAW DRIVE |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Manufacturer Phone | 6503991787 |
| Manufacturer G1 | MINERVA SURGICAL, INC. |
| Manufacturer Street | 101 SAGINAW DRIVE |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM |
| Generic Name | ENDOMETRIAL ABLATION DEVICE |
| Product Code | MNB |
| Date Received | 2020-02-07 |
| Model Number | MIN9770 |
| Catalog Number | MIN9770 |
| Lot Number | 19K09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-02-07 |