MAUDE Adverse Event Report: MINERVA SURGICAL, INC. MINERVA SINGLE STERILE DISPOSABLE HANDPIECE; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number MIN9770

Device Problems Self-Activation or Keying (1557); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

Device would not stay green.The arrow on the machine would wander from green to red and end up in red with both handpieces.Called representative and is aware.Both handpieces are dirty and in their boxes in specimen room.

• Brand Name: MINERVA SINGLE STERILE DISPOSABLE HANDPIECE
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• MDR Report Key: 11619069
• MDR Text Key: 243974175
• Report Number: 11619069
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MIN9770
• Device Catalogue Number: MIN9770
• Device Lot Number: 20L19-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1