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

Model Number	MAL-1001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
While removing the malyugin ring from the eye, the surgeon noticed small gold flecks in the eye.Some were removed during the irrigation process but it was noticed in the follow up that there were still 3 gold flecks noticed: one on the iris and 2 in the incision.Surgeon stated that none of the other devices that were used during surgery had any gold on them.In normal post-op schedule and drops, the outcome was reported good with no patient harm reported.

• Brand Name: MALYUGIN RING SYSTEM
• Common Device Name: CLIP, IRIS RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98952
• Manufacturer Contact: jeffrey cody ; 8415 154th ave ne; redmond, WA 98052
• MDR Report Key: 17376103
• Report Number: 3019924-2023-00003
• Device Sequence Number: 12388792
• Product Code: HOC
• UDI-Device Identifier: 10844685006127
• UDI-Public: 10844685006127
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAL-1001
• Device Catalogue Number: MAL-1001
• Device Lot Number: 170438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (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: Other
• Patient Sex: Unknown