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 Uterine Perforation (2121)

Event Date 09/27/2021

Event Type  Injury  

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 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
• 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: 12701544
• MDR Text Key: 278535956
• Report Number: 3011011193-2021-00023
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

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