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

Model Number	MAL-0002
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The malyugin ring has 4 scrolls (eylets) that hook onto iris.During the case the surgeon reported an eyelet was previously fused, would not engage and bent toward the center.After several attempts of trying to engage, it was removed and replaced by another malyugin ring.After the case, the eylet was found defective.Corneal edema caused by disrupting endo and descemets was reported.Steroids were prescribed to treat the patient.Full patient recovery reported.

• Brand Name: MALYUGIN RING SYSTEM
• Common Device Name: IRIS RETRACTOR CLIP
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGIES, INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY, INC; 8415 154th ave ne; redmond WA 20630 8392
• Manufacturer Contact: jeffrey cody ; 8415 154th ave ne; redmond, WA 98052 ; 2063083926
• MDR Report Key: 17403090
• Report Number: 3019924-2022-00006
• Device Sequence Number: 17614314
• Product Code: HOC
• UDI-Device Identifier: 10844685000040
• UDI-Public: 10844685000040
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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: 09/28/2025
• Device Model Number: MAL-0002
• Device Catalogue Number: MAL-0002
• Device Lot Number: 158987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female