MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH HYSTEROLUX FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number 72205000

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

Hysteroscopy machine began to say there was a negative ml fluid deficit.Picture taken of machine saying -135ml fluid deficit.This does not allow for accurate fluid deficit management.Call placed to rep during case.No user error was identified.This brand of machine has been known to malfunction this way many times before.

• Brand Name: HYSTEROLUX FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th street; orlando FL 32811
• MDR Report Key: 17938867
• MDR Text Key: 325720264
• Report Number: 17938867
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2023

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 Catalogue Number: 72205000
• Device Lot Number: 2106CE0294
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female