MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE TUBING; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 10-401FC

Device Problem Defective Device (2588)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Myosure tubing connected to fluent fluid manager was not working properly resulting in the surgeon being unable to circulate saline through the tubing during surgery - no adverse event to patient.Fda safety report id# (b)(4).

• Brand Name: MYOSURE TUBING
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 15498905
• MDR Text Key: 300786854
• Report Number: MW5112300
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10-401FC
• Device Lot Number: 22E26RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic