MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE USA, INC HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET; INSUFFLATOR, HYSTEROSCOPIC

Model Number	72205028
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Covidien hysteroscopy tubing fell apart where tubing is inserted into hysteroscopy machine.

• Brand Name: HYSTEROLUX HYSTEROSCOPIC INFLOW TUBE SET
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE USA, INC; 4531 36th street; orlando FL 32811
• MDR Report Key: 20480612
• Report Number: 20480612
• Device Sequence Number: 8166454
• Product Code: HIG
• UDI-Device Identifier: 04056702005795
• UDI-Public: (01)04056702005795
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/27/2024
• Report Date (Section F): 09/27/2024

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 Model Number: 72205028
• Device Catalogue Number: 72205028
• Device Lot Number: 4029194
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/27/2024