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

Model Number FG-0201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/24/2021

Event Type  Injury  

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 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
• Type of Device: SYMPHION RD- RESECTING DEVICE 3.6
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• Manufacturer (Section G): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara 95054
• Manufacturer Contact: veronica williams ; 4255 burton drive; santa clara 95054 ; 6503991771
• MDR Report Key: 12524005
• MDR Text Key: 273085717
• Report Number: 3011011193-2021-00019
• Device Sequence Number: 1
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG-0201
• Device Catalogue Number: FG-0201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization