MAUDE Adverse Event Report: MINERVA SURGICAL, INC. SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM, RESECTING DEVICE 3.6; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Catalog Number FG-0201

Device Problem Use of Device Problem (1670)

Patient Problems Abdominal Pain (1685); Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported physician performed a procedure, using the symphion operative hysteroscopy system, on an 80 year old patient with a hypotrophic uterus with a thin myometrium.At the end of the procedure, secondary to the thin myometrium, the uterine wall was inadvertently perforated during active resection.Subsequently the system shut down, as designed, and the procedure was aborted.The patient was discharged the same day.Later that evening, the patient experienced abdominal pain and went to er.Bowel damage was suspected and confirmed laparoscopically.Damage was limited to an unintended thermal effect on small bowel, inflicted during active resection at the time of perforation.A general surgeon was called for a consultation and a small bowel resection with an end to end anastomosis was performed.Patient was released from the hospital 5 days later and is reportedly doing well.

Manufacturer Narrative

Manufacturer contacted the physician to obtain additional information related to this event.An unintended thermal effect on the small bowel was confirmed.Patient was released from the hospital 5 days later and is reportedly doing well.Based on the information provided, there is no indication the system malfunctioned during the procedure and shut down, as designed.All resecting devices meet all qa specifications prior to being released, including adequate sterilization.Warnings and cautions related to an event of this nature are included in the ifu for symphion operative hysteroscopy system, including but not limited to: do not use the symphion system in patients where anatomy does not support an endoscopic procedure (i.E.Cervical stenosis, existence of an iud, or in conditions that limit access to the target tissue).Excessive force on the resecting device tip does not improve resection performance and may increase the risk of perforation or device damage.Excessive force applied during insertion or removal of the resecting device may result in device damage or tissue injury including perforation.Insertion and removal of the resecting device should always be under direct visualization.Do not activate the resecting device unless the resecting window and tip are immersed in a saline environment.Electrodes may arc if activated in air, damaging the device.Potential complications of continuous flow endoscopic surgery include: uterine perforation, damage to adjacent organs, pelvic cramping, abdominal pain, damage to healthy tissue.

• Brand Name: SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM, RESECTING DEVICE 3.6
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• Manufacturer (Section G): MINERVA SURGICAL, INC.; 4255 burton drive; santa clara CA 95054
• Manufacturer Contact: michelle becker ; 4255 burton drive; santa clara, CA 95054
• MDR Report Key: 16654823
• MDR Text Key: 312412641
• Report Number: 3011011193-2023-00010
• Device Sequence Number: 1
• Product Code: PGT
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: FG-0201
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/31/2023
• 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; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female