MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-20 for MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM MIN9770 manufactured by Minerva Surgical, Inc..
[175593583]
The device used in this case was not returned. A device history review was conducted for the lot number that was reported. The handpiece met all qa specifications. Manufacturer investigation did not produce sufficient information to establish the root cause of the event. The warning section for the minerva endometrial ablation system operator's manual indicates: "forcibly advancing the minerva disposable handpiece against resistance is likely to increase the risk of perforation or creation of a false passage. " the caution section for the minerva endometrial ablation system operator's manual indicates: "a false passage can occur during any procedure in which the uterus is instrumented, especially in cases of a severe anteverted retroflexed or a laterally displaced uterus. Use caution to ensure that the minerva disposable handpiece is properly positioned in the uterine cavity. "
Patient Sequence No: 1, Text Type: N, H10
[175593584]
Manufacturer was informed that an adverse event took place that required bowel resection and hysterectomy. After multiple attempts, the investigation of this event did not produce results and the reported event could not be confirmed or refuted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011011193-2020-00001 |
| MDR Report Key | 9608586 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-20 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2019-05-16 |
| Date Added to Maude | 2020-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-01-20 |
| Model Number | MIN9770 |
| Catalog Number | MIN9770 |
| Lot Number | 19K14-01 |
| 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 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-20 |