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-100CBS
Medical Device Problem Code	Measurement System Incompatibility (2982)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction

• 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; w.o.m. world of medicine gmbh; siemensdamm 58; berlin, berlin 13627 ; GM 13627
• Manufacturer (Section G): W.O.M. World of Medicine GmbH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sushira panchama ; w.o.m. world of medicine gmbh; siemensdamm 58; berlin, berlin 13627 ; GM 13627
• MDR Report Key: 50249288
• Report Number: 3001556604-2026-00001
• Device Sequence Number: 10008153
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 010405670200655611180905211809CE0126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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-100CBS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown