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

Model Number AQL-100CS

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 315368610
• Report Number: 3002914049-2023-00003
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: AQL-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1