MAUDE Adverse Event Report: COVIDIEN HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET; INSUFFLATOR, HYSTEROSCOPIC

Model Number 72205028

Device Problems Leak/Splash (1354); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem Exposure to Body Fluids (1745)

Event Type  malfunction  

Event Description

Plastic seal on cassette on hysteroscopic inflow tube set isn't sealed and fluid spraying out.

• Brand Name: HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16930064
• MDR Text Key: 315288925
• Report Number: MW5117515
• Device Sequence Number: 1
• Product Code: HIG
• 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: 05/09/2023

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
• Device Model Number: 72205028
• Device Lot Number: 4024870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1