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	Uterine Perforation (2121)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The resecting device was not returned for investigation.Physical product examination is not possible.Based on the description of hysteroscopic image and more specifically the "synechia" type tissue, it is likely that the symphion procedure was initiated and conducted in an unrecognized false passage, which ultimately led to a uterine perforation.Uterine perforations are known complications of polypectomy.Complications associated with uterine perforations are addressed in the warning section of the operator's manual and instructions for use, including the statements: use caution not to perforate the uterine wall when sounding, dilating, or inserting the resecting device.Excessive force applied during placement of the resecting device may result in tissue injury, including perforation.Clinical judgment must always be used.
Event or Problem Description
It was reported that a symphion polypectomy was performed by an ob/gyn resident.The case according to the report was challenging (details unknown).At the time of hysteroscope insertion, it was reported that the user saw (based on description) synechia type tissue and decided to "clean" the cavity.After about 5 minutes of "cleaning" a uterine perforation was suspected, based on sudden loss of fluid and visualization of the organs of the abdominal cavity.The case was aborted.

• 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: 12701544
• Report Number: 3011011193-2021-00023
• Device Sequence Number: 1364431
• Product Code: PGT
• UDI-Device Identifier: 08714729863656
• UDI-Public: 08714729863656
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/26/2021

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: 09/27/2021
• Initial Report FDA Received Date: 10/26/2021
• 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: Required Intervention