MAUDE Adverse Event Report: HOLOGIC LIMITED PARTNEP AQUILEX PUMP ASSY; AQULEX PUMP ASSY

Model Number AQL-100P

Device Problem Leak/Splash (1354)

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

Event Date 02/24/2015

Event Type  Injury  

Event Description

The gynecologist opted to proceed with a endometrial ablation by using the cysto gyrus roller ball electrode.During the procedure, an irrigation system is used for all endometrial ablations.This system, aquilex, did not function appropriately.The surgeon/staff could not create an adequate seal and pressurize the uterus.They reviewed the sop and the mfr's instructions posted on the machine.A system test was performed on the aquilex and it came back correct.Fluid was found to be leaking at the hysteroscope end.A second hysteroscope was used but it still leaked.The aquilex machine setup was repeated with new tubing.The hysteroscope assembly was verified from mfr's ifu.The attending attempted to use the aquilex for several minutes and then opted to disconnect from the aquilex and attempted doing the procedure by gravity.Visualization of the operative field was inadequate, and the surgeon elected to abort.

• Brand Name: AQUILEX PUMP ASSY
• Type of Device: AQULEX PUMP ASSY
• Manufacturer (Section D): HOLOGIC LIMITED PARTNEP
• MDR Report Key: 4577789
• MDR Text Key: 5553045
• Report Number: MW5041258
• Device Sequence Number: 1
• Product Code: HIH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2015

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-100P
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR