MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM,

Model Number	AQL-100CS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	07/17/2023
Type of Reportable Event	Death
Event or Problem Description
We have been informed of the following event: "technical support was contacted by a.Mirante - territory manager tm who reported that he was present for a tissue removal procedure using myosure and aquilex.The procedure was going normal the deficit was steady at 1000-1300 and would increase slightly while removing the tissue.The doctor then thought she saw something that looked like a perforation.At that point the deficit was increasing quickly, at 2500 the doctor stopped the procedure.The tm then left the room since the doctor mentioned that they were going to do an echocardiogram on the patient along with some other tests.This procedure took place around 9 am and later in the day he received a call from the doctor telling him that the patient had passed away.The cause of death was unknown.Myosure - case: (b)(4).".
Additional Manufacturer Narrative
In the case described, a small perforation was assumed, which also explains the increase in deficit shortly after the perforation was assumed.Uterine perforation is a potential complication of all intrauterine procedures and can be associated with injury to surrounding blood vessels or other organs (e.G.Bladder or in-testine).If during a hysteroscopic procedure an obvious source of high fluid loss is not identified, laparoscopic assessment of potential cervical or uterine perforation should be made.The most probable cause is uterine perforation, which may have led to the death of the patient.Since the end user did not return the device and did not respond to further questions, we cannot rule out a malfunction of the device and therefore the event is reportable.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM,
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 17570491
• Report Number: 3002914049-2023-00007
• Device Sequence Number: 15704942
• Product Code: HIG
• UDI-Device Identifier: 04056702002121
• UDI-Public: 04056702002121
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: AQL-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female