MAUDE Adverse Event Report: HOLOGIC GYN SURGICAL SOLUTIONS MYOSURE CONTROLLER

Device Problem Mechanical Jam (2983)

Patient Problems Hypoxia (1918); Pulmonary Edema (2020)

Event Date 02/24/2015

Event Type  Injury  

Event Description

During hysteroscopy the fluid deficit was not correct on the pump.The handpiece also jammed and was replaced.New handpiece showed fluid deficit rapidly rise.Pump deficit read 7800 ml.Manual calculation deficit was 4000 ml.Developed pulmonary edema from excess saline post operation hypoxic.

• Brand Name: MYOSURE CONTROLLER
• Type of Device: MYOSURE CONTROLLER
• Manufacturer (Section D): HOLOGIC GYN SURGICAL SOLUTIONS
• MDR Report Key: 4643460
• MDR Text Key: 5578680
• Report Number: MW5041701
• Device Sequence Number: 1
• Product Code: HIH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 56