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

Model Number	AQL-100PBS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event description is very poor and general.At the time of the reporting decision the device has not yet been returned for evaluation and the evaluation results were not available.With this limited information the most probable root cause could not be deter-mined.It could be a device independent issue or an actual malfunction.The procedure was successfully completed using the same system.No patient harm or injury reported.In case of a potential malfunction, we cannot exclude that it could cause or contribute to serious injury if it were to reoccur.If new information is received, or if the device is returned for evaluation, the reporting decision will be re-evaluated accordingly.
Event or Problem Description
We have been informed of the following event: "issue reported: at mid-case for approximately 3 minutes, the deficit was showing as a negative number.Troubleshooting performed and additional details: right before ending the case, the negative sign went away to show a final positive deficit.Procedure was complete and patient was unharmed.Gss ts confirmed deficit test was not performed post op.Customer did not change the supply bag, canister, or any tubing when this event occured.Final deficit reading on pump was 235mls; manual count not performed.How did the procedure complete: with the same equipment procedure setting: clinical date of procedure: on (b)(6) 2025.".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SETS
• 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 poststr. 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sushira panchama ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 23308283
• Report Number: 3002914049-2025-00003
• Device Sequence Number: 5814704
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172040
• 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): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AQL-100PBS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female