MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-29 for MINERVA SURGICAL ENDOMETRIAL ABLATION SYSTEM MIN9770 manufactured by Minerva Surgical, Inc..
[177369842]
Patss is a known potential adverse event of endometrial ablation and is independent of the modality used. The general warnings section of the operator's manual and the instruction for use state: "patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterectomy. This can occur as late as 10 years post procedure. " in addition the other adverse events section of the operator's manual and the instruction for use state: "the following adverse events could occur or have been reported in association with the use of other endometrial ablation systems and may occur when the minerva system is used: post-ablation tubal sterilization syndrome. "
Patient Sequence No: 1, Text Type: N, H10
[177369843]
It has been reported that subsequent to a minerva ablation (details of the procedure unknown) the patient developed a post-ablation tubal sterilization syndrome (patss) which required hysteroscopic adhesiolysis, and rollerball ablation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011011193-2020-00002 |
| MDR Report Key | 9644472 |
| Report Source | OTHER |
| Date Received | 2020-01-29 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-07-31 |
| Device Manufacturer Date | 2019-05-16 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| Model Number | MIN9770 |
| Catalog Number | MIN9770 |
| 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. Required No Informationntervention | 2020-01-29 |