MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH TUBE SET FOR IRRIGATION, SINGLE-USE; INSUFFLATOR, HYSTEROSCOPIC

Model Number AQL-110

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Event Description

When plugging into the hysteroscopy pump, the tubing started leaking by the rfid hub.Product did not have patient contact and no harm to patient.Failed product is available to be returned to the manufacturer.New tubing was opened to complete the procedure.

• Brand Name: TUBE SET FOR IRRIGATION, SINGLE-USE
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th st; orlando FL 32811
• MDR Report Key: 9652876
• MDR Text Key: 177157268
• Report Number: 9652876
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2019

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: AQL-110
• Device Catalogue Number: AQL-110
• Device Lot Number: K19BO56
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1