MAUDE Adverse Event Report: THERMEDX, LLC 37-5 FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Catalog Number LL0002

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2016

Event Type  malfunction  

Event Description

Hysteroscopy luer lock tubing set, thermedx catalog number ll0002; inflow tubing connection broke off.Opened new kit and replaced it.

• Brand Name: 37-5 FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): THERMEDX, LLC; 31200 solon road; unit 1; solon OH 44139
• MDR Report Key: 6045673
• MDR Text Key: 58025355
• Report Number: 6045673
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: LL0002
• Device Lot Number: 1532017
• 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: 07/19/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 89