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

Catalog Number 72205000

Patient Problem Insufficient Information (4580)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

Difficulty with hysteroscopic fluid management that resulted in inability to adequately measure hysteroscopic fluid deficit.Loss of unquantifiable amounts of fluid on the floor.No final measurement of the hysteroscopic fluid deficit could be performed due to massive spillage.(hysteroscopy was complicated by difficulty with calibration of the fluid management system, as well as spillage of large amounts of hysteroscopic fluid on the floor, which resulted in continuous error messages about large fluid deficit; however, a large amount of unquantifiable fluid deficit was lost on the floor due to spillage that was mopped up by the blankets.No evidence of complication on the operative field were visualized.).

• Brand Name: HYSTEROLUX
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th street; orlando FL 32811
• MDR Report Key: 18517170
• MDR Text Key: 332911492
• Report Number: 18517170
• 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: 12/28/2023

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 Catalogue Number: 72205000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: White