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

Catalog Number FG-0202

Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)

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.Lab results of patient's blood pathogen tests were negative.No harm to the nurse was reported.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.Section 15 of the symphion operative hysteroscopy system user's manual (l0158, rev a.) provides detailed instructions for disassembly following a procedure, including waiting a minimum of 60 seconds for any fluid pressure to dissipate from the tubing set.Section 15.2 provides the following instructions for tissue catch disassembly: a) disconnect both quick connect fittings from the tissue catch b) unthread the tissue catch cap and remove cap and tissue bag to access resected tissue.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 the or clean-up, the nurse unscrewed the tissue catch cap.When the nurse screwed cap back onto the tissue catch, the patient fluid from the tissue catch splashed into the nurse's eye.The tissue catch containing the patient's fluid was sent to the blood lab to test for potential blood borne pathogen exposure.Lab results of patient's blood pathogen tests were negative.No harm to the nurse was reported.

• Brand Name: SYMPHION OPERATIVE HYSTEROCOPY 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: 17628789
• MDR Text Key: 322020576
• Report Number: 3011011193-2023-00024
• 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: 08/25/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/26/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other