MAUDE Adverse Event Report: MINERVA SURGICAL, INC. SYMPHION RD- RESECTING DEVICE 3.6

Model Number	FG-0201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The resecting device was not returned for investigation.Physical product examination is not possible.Initially suspected injuries were not confirmed.This report is filed due to overnight hospitalization for observation.
Event or Problem Description
The company was made aware that a hysteroscopic polypectomy using the symphion system was performed.During the otherwise uneventful procedure, doctor noticed a sudden loss of fluid totaling approximately 700cc.At that time the polypectomy had been completed.Doctor suspected a uterine perforation and possible bladder perforation.None were subsequently confirmed.The patient was kept overnight for observation and discharged.

• Brand Name: SYMPHION RD- RESECTING DEVICE 3.6
• Common Device Name: SYMPHION RD- RESECTING DEVICE 3.6
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• MDR Report Key: 12524005
• Report Number: 3011011193-2021-00019
• Device Sequence Number: 4291128
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG-0201
• Device Catalogue Number: FG-0201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization