MAUDE Adverse Event Report: MINERVA SURGICAL INC SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM; CLOSED LOOP HYSTEROSCOPIC INSUFFLATOR

Catalog Number FG-0202

Device Problem Connection Problem (2900)

Patient Problems Exposure to Body Fluids (1745); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  Injury  

Manufacturer Narrative

Minerva surgical made attempts to obtain additional information and status of lab results.No additional information is available at this time.The disposable fluid management accessory (subject device) used in this case was not returned, and therefore a failure analysis of the subject device could not be performed.The lot number of the subject device was not provided; therefore, a device history review could not be performed.Due to the limited information available and the subject device was not returned by customer, root cause could not be determined.Minerva surgical will continue to monitor complaint and if additional relevant information becomes available, a supplemental report will be submitted.

Event Description

It was reported during a procedure, the quick-connect component on the tissue catch spontaneously disconnected and the patient's tissue fluid from the tissue catch splashed into a nurse's eye.The nurse reconnected the tubing to the tissue catch and continued the procedure with no further impact to the patient or procedure.The tissue catch containing the patient's fluid was sent to the blood lab to test for potential blood borne pathogen exposure.No harm to the nurse was reported.

• Brand Name: SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM
• Type of Device: CLOSED LOOP HYSTEROSCOPIC INSUFFLATOR
• 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 ; 9787601704
• MDR Report Key: 17628788
• MDR Text Key: 322020865
• Report Number: 3011011193-2023-00023
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FG-0202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• 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): Other