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

Model Number MAL-0002-1

Device Problem Use of Device Problem (1670)

Patient Problem Tissue Damage (2104)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Upon removal from the eye the ring pinched the iris causing a tear.The device was not returned for evaluation and the lot number of the device was not provided.Further investigation revealed the surgeon was not following the recommended method for removing the ring from eye as stated in the dfu.The facility reported that the patient is doing much better 3 months post op.

Event Description

Malyugin ring was being removed from the eye the user felt that the ring was difficult to remove, pinched on the iris and caused an iris tear.

• Brand Name: MST MALYUGIN RING SYSTEM
• Type of Device: CLIP, IRIS RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: cecil chrisinger ; 8415 154th ave ne; redmond, WA 98052 ; 4252843769
• MDR Report Key: 9182069
• MDR Text Key: 162446568
• Report Number: 3019924-2019-00007
• Device Sequence Number: 1
• Product Code: HOC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAL-0002-1
• Device Catalogue Number: MAL-0002-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other