MAUDE Adverse Event Report: COVIDIEN COVIDIEN HYSTEROLUX; INSUFFLATOR, HYSTEROSCOPIC

Model Number 72205028

Patient Problem Insufficient Information (4580)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

Product cartridge / cassette that sits in console came apart again.

• Brand Name: COVIDIEN HYSTEROLUX
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 18192036
• MDR Text Key: 328959324
• Report Number: MW5148371
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/17/2023

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: 4026382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1