MAUDE Adverse Event Report: HOLOGIC, INC AQUILEX PUMP; INSUFFLATOR, HYSTEROSCOPIC

Device Problem Suction Problem (2170)

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

Event Date 04/12/2019

Event Type  malfunction  

Event Description

The outflow tract would not function, it would not suck up.Checked device afterwards and seemed to be working.Manufacturer response for fluid management system, aquilex pump (per site reporter).Took the unit and shipped a replacement next day.

• Brand Name: AQUILEX PUMP
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 8607316
• MDR Text Key: 144956388
• Report Number: 8607316
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2019
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA