MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Model Number AQUILEX AQL-100P

Device Problem Defective Component (2292)

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

Event Date 07/20/2020

Event Type  Injury  

Event Description

In the middle of pt's case, the fluid management system malfunctioned.At this point, manual calculations needed to be done to track fluid management.Fda safety report id # (b)(4).

• Brand Name: HOLOGIC FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 10312097
• MDR Text Key: 200282634
• Report Number: MW5095675
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2020

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: AQUILEX AQL-100P
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 63