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

Model Number AQL-100

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pulmonary Edema (2020)

Event Date 06/02/2017

Event Type  Injury  

Event Description

During the first 15 minutes of the operative portion of the case, we were asked by the myosure representative to "prime" the fluid management system two or three times.We were then told it was "malfunctioning," since it was telling us the deficit was only 200 ccs.At this time, there was a large amount of water that had spilled on the floor, although the case was nearing completion.Eleven liters had been infused, but we didn't know how much fluid had actually been absorbed, versus spilled on the floor.Simultaneously, the anesthesiologist reported that the patient had laryngospasm and she needed to intubate due to trouble achieving oxygenation.The patient was suffering from acute pulmonary edema and emergency measures were taken to treat the condition.The patient left the operating room intubated and spent the night in icu.She was discharged home the following morning.The device in question was a loaner provided by the manufacturer rep.We do not have the serial number of the fluid management system.

Event Description

During the first 15 minutes of the operative portion of the case, we were asked by the myosure representative to "prime" the fluid management system two or three times.We were then told it was "malfunctioning," since it was telling us the deficit was only 200 ccs.At this time, there was a large amount of water that had spilled on the floor, although the case was nearing completion.Eleven liters had been infused, but we didn't know how much fluid had actually been absorbed, versus spilled on the floor.Simultaneously, the anesthesiologist reported that the patient had laryngospasm and she needed to intubate due to trouble achieving oxygenation.The patient was suffering from acute pulmonary edema and emergency measures were taken to treat the condition.The patient left the operating room intubated and spent the night in icu.She was discharged home the following morning.The device in question was a loaner provided by the manufacturer rep.We do not have the serial number of the fluid management system.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; aylin perry; 4531 36th st.; orlando FL 32811
• MDR Report Key: 6964762
• MDR Text Key: 89829496
• Report Number: 6964762
• 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,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AQL-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 31 YR