MAUDE Adverse Event Report:; HYSTEROSCOPY FLUID

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Information (3190)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

Hysteroscopy fluid deficit.

• Type of Device: HYSTEROSCOPY FLUID
• MDR Report Key: 4293450
• MDR Text Key: 21721581
• Report Number: 4293450
• Device Sequence Number: 1
• Product Code: LTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/15/2014

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: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR