MAUDE Adverse Event Report: THERMEDX, LLC. THERMEDX HYSTEROSCOPY MACHINE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  Other  

Event Description

The patient was having a hysteroscopic myomectomy and the operation room nurse added a new bag of glycine and the deficit amount on the hysterocopy machine immediately went from 280 to 0.The representative for the machine (which was just purchased) came in on (b)(6) /2014 and checked the machine.No issues were found.There were no injuries or issues with the patient as a result of this event.

• Brand Name: THERMEDX HYSTEROSCOPY MACHINE
• Type of Device: HYSTEROSCOPY MACHINE
• Manufacturer (Section D): THERMEDX, LLC.; solon OH 44139
• MDR Report Key: 4645269
• MDR Text Key: 5685110
• Report Number: MW5041711
• Device Sequence Number: 1
• Product Code: HIG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/13/2015

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 120