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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; INSUFFLATOR, HYSTEROSCOPIC
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W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
Event Type  Other  
Event Description
During room set up for hysteroscopy case, scrub tech and registered nurse (rn) was preparing the aquilex machine to use for the case.After connecting the aquilex tubing to the machine and 3l bag of saline, rn pressed the prime button but it did not prime correctly, an error pop up on the machine that says "high leakage check cord".We tried to restart the machine but it still did not prime.Scrub tech, who is knowledgeable was notified and sought for help.She suggested to change the tubing.We changed the tubing, restarted the machine and restarted the whole priming process.While priming the second tubing, an error popped up again on the machine that says "change bag" and after pressing resume it primed properly.The second tubing was primed successfully.The procedure was done, and supervisor was notified and was told to save the tubing so we can report the defective tubing.
 
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Brand Name
AQUILEX FLUID CONTROL SYSTEM
Type of Device
INSUFFLATOR, HYSTEROSCOPIC
Manufacturer (Section D)
W.O.M. WORLD OF MEDICINE GMBH
4531 36th street
orlando FL 32811
MDR Report Key18777134
MDR Text Key336207851
Report Number18777134
Device Sequence Number1
Product Code HIG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2023
Date Report to Manufacturer02/26/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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