MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. MALYUGIN RING SYSTEM 7.0MM; CLIP, IRIS RETRACTOR

Model Number MAL-0002-1

Device Problem Defective Device (2588)

Patient Problems Loss of Vision (2139); Swelling/ Edema (4577)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

One of the 4 rings was fused together.Patient came in for an appointment after and had some edema and vision loss, likely from the defective ring.

• Brand Name: MALYUGIN RING SYSTEM 7.0MM
• Type of Device: CLIP, IRIS RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; 8415 154th ave ne; redmond WA 98052
• MDR Report Key: 15914443
• MDR Text Key: 304787209
• Report Number: 15914443
• Device Sequence Number: 1
• Product Code: HOC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAL-0002-1
• Device Catalogue Number: MAL-0002-1
• Device Lot Number: 158987
• 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: 11/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Race: Black Or African American