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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the reporting decision the device has not yet been returned for evaluation and the end user did not respond to further enquiries.There can be many reasons if the deficit indicated by the pump does not correspond to the expected deficit, including uterine perforation, non-return of irrigation fluid to the waste containers, so the system cannot calculate the deficit (e.G.Fluid remaining on the floor, doctor's clothing or under-buttocks-drape; use of additional suction system with its own collection containers), wrong manual determination of the deficit or an actual malfunction of the device.Therefore, the most possible root cause could either be a device-independent issue or an actual malfunction.In addition, the last preventive maintenance for the pump is overdue; the serial number has not been transmitted for the scale.Patient harm has not been reported.
Event or Problem Description
We have been informed of the following event: "brief description: incorrectly calculating deficit problem description.Problem description caller: hologic employee name: (b)(6) for account (if not reporter): (b)(6) part reporting description: aql-100p date product support or hologic employee notified of issue reported: (b)(6).Date of procedure: (b)(6) 2023.Issue reported: incorrectly calculating deficit.Troubleshooting performed: customer reports that system is incorrectly calculating deficit.No further.Information is available.Patient status: no injury reported or pae.Dr.Who performed the procedure: unknown.How did the procedure complete: unknown.Patient/user impact: no impact reported".

• 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: 16944917
• Report Number: 3002914049-2023-00003
• Device Sequence Number: 6554961
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/17/2023

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-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/17/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown