MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT HOLOGIC KIT; HYSTEROSCOPE (AND ACCESSORIES)

Device Problems Break (1069); Noise, Audible (3273)

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

Event Date 03/02/2023

Event Type  malfunction  

Event Description

During set up, fluent hologic kit was connected to myosure machine.Machine indicated error, requiring machine to be turned off/restarted.Following restart and audible clicking sound, it was determined that part of kit was broken and nonfunctionable.New kit was obtained and utilized, no apparent harm to patient.

• Brand Name: FLUENT HOLOGIC KIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 16529184
• MDR Text Key: 311167056
• Report Number: MW5115652
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• 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: 03/08/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MYOSURE MACHINE
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White