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

Lot Number 362873

Device Problem Suction Failure (4039)

Patient Problem Insufficient Information (4580)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

Suction was not working on myosure fluid machine.The machine was unplugged and turned on again but still no suctioning.The procedure continued with manual suction and manual fluid measurements.

• Brand Name: AQUILEX FLUID MANAGEMENT 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: 12810619
• MDR Text Key: 280759532
• Report Number: 12810619
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2021

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 Lot Number: 362873
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Female