MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY MALYUGIN RING; EXPANDER, TISSUE, ORBITAL

Model Number 6.25MM MALYUGINRING

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 07/28/2014

Event Type  Injury  

Event Description

During intraocular surgery, a 5.25mm malyugin ring was utilized to help with poor dilation.Surgery was uneventful.On removal of the malyugin ring, the prolene junction that is glued, separated.We were able to remove the ring without incident or complication.

• Brand Name: MALYUGIN RING
• Type of Device: EXPANDER, TISSUE, ORBITAL
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY; redmond WA 98052
• MDR Report Key: 4187650
• MDR Text Key: 5094979
• Report Number: 4187650
• Device Sequence Number: 1
• Product Code: HOC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2014

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: Health Professional
• Device Model Number: 6.25MM MALYUGINRING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2014
• Distributor Facility Aware Date: 09/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention