MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. MALYUGIN RING 2.0 SYSTEM; CLIP, IRIS RETRACTOR

Model Number	MAL-1001
Medical Device Problem Codes	Mechanical Problem (1384); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Eye Injury (1845); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The malyugin ring came out of the injector upside down it could not be manipulated and caused a tear in the iris.
Additional Manufacturer Narrative
The surgeon advised manufacturer that the malyugin ring had been inserted correctly but the interior scroll had a defect and was unable to hook onto the iris like the other three had done.The malyugin was removed and another one was inserted without issue and the iris remained intact.The surgeon reported that while there was a minor issue with the malyugin, the patient did not experience any harm.
Event or Problem Description
The malyugin ring came out of the injector upside down it could not be manipulated and caused a tear in the iris.

• Brand Name: MALYUGIN RING 2.0 SYSTEM
• Common Device Name: CLIP, IRIS RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; 8415 154th ave ne; redmond WA 98036
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY, INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: patricia beauregard ; 8415 154th ave ne; redmond, WA 98036 ; 4255560544
• MDR Report Key: 17402971
• Report Number: 3019924-2023-00009
• Device Sequence Number: 7358068
• Product Code: HOC
• UDI-Device Identifier: 10844685006127
• UDI-Public: 10844685006127
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/AN/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2026
• Device Model Number: MAL-1001
• Device Catalogue Number: MAL-1001
• Device Lot Number: 172940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown