MAUDE Adverse Event Report: MINERVA SURGICAL INC SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM; HYSTEROSCOPI 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 09/29/2023

Event Type  Injury  

Event Description

It was reported during a procedure, the controller alerted the user of kinked tubing during the procedure and a leak was observed at the tissue catch cap.A minerva representative attempted to tighten the cap, she observed that the quick connect tubing on the cap top was loose and slightly pushed back.When attempting to push the quick connect into place, the quick connect burst open.The patient's tissue fluid from the tissue catch splashed into the minerva representative's eye.The tubing was reconnected and the procedure continued with no 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.

Manufacturer Narrative

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 and a device history review was unable to be performed.Potentially, the quick connect button was inadvertently depressed during handling.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.

• Brand Name: SYMPHION OPERATIVE HYSTEROSCOPY SYSTEM
• Type of Device: HYSTEROSCOPI 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: 18020751
• MDR Text Key: 326717551
• Report Number: 3011011193-2023-00026
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2023

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-0202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/27/2023
• 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