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

Model Number	MAL-0002-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The procedure was completed as planned.
Event or Problem Description
Upon removal of the malyugin ring there was an iris tear and some bleeding occurred.

• Brand Name: MALYUGIN RING SYSTEM
• Common Device Name: IRIS CLIP RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• MDR Report Key: 10532820
• Report Number: 3019924-2020-00005
• Device Sequence Number: 3055989
• Product Code: HOC
• UDI-Device Identifier: 00844685000043
• UDI-Public: 00844685000043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

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 Expiration Date: 03/18/2023
• Device Model Number: MAL-0002-1
• Device Catalogue Number: MAL-0002
• Device Lot Number: 121177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/14/2020
• 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