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

Model Number HOLOGIC BVBA

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

Tubing would not prime kept stating there was an error (securing flow pack).Pt was not affected, was not in the room, tubing changed before pt was in room.

• Brand Name: HOLOGIC FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 10755276
• MDR Text Key: 213887021
• Report Number: MW5097526
• Device Sequence Number: 1
• Product Code: HIG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: HOLOGIC BVBA
• Device Lot Number: 20F30RF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 46 YR
• Patient Weight: 124