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

Model Number AQL-100P

Device Problems Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2017

Event Type  malfunction  

Event Description

Hysteroscopy with myomectomy using myosure started.Immediately after surgeon placed scope in patient surgeon noted that the aqualix hysteroscopy machine had registered a deficit of 300 ml of fluid.All areas of surgery checked for possible area of leakage of fluid, and the drainage bag on the field was noted to have approximately 300 ml of fluid present.That fluid was suctioned into the suction canister on the hysteroscopy machine.Surgeon proceeded with surgery and the deficit increase did not match what was visible in the saline bags and suction canisters.Each time the surgeon stopped, it was noted that the amount in the full 3000 ml suction canisters was equal to the number of empty 3000 ml saline bags.Surgery ended at 1140 with the hysteroscopy machine showing a deficit of 3100 ml.At that time, there were 8 full 3000 ml canisters and the 9th canister had 2300 ml present.There were 9 empty 3000 ml saline bags.Surgeon determined the deficit to be 750 ml.At no time was there any detrimental changes in the patient's vitals.Patient was taken to post-anesthesia care unit (pacu) in stable condition.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th st.; orlando FL 32811
• MDR Report Key: 7475264
• MDR Text Key: 106984017
• Report Number: 7475264
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

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: No Information
• Device Model Number: AQL-100P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR