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

Model Number MAL-0002-1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The doctor reported that he had experienced malyugin rings breaking at the glue joint upon removal from the eye.There was no impact to the patient and the procedure was completed as planned.There were other unsubstantiated reports of malyugin rings breaking from the facility.

Manufacturer Narrative

The surgeon reported that he was using forceps to remove the ring from the eye contrary to the instructions for use which instruct to use the inserter for removal.At the time of this report no product had been returned for evaluation and no information about this or any other ring breaks was available.This is the fourth of four reports.

• Brand Name: MALYUGIN RING SYSTEM
• Type of Device: IRIS CLIP RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; redmond WA
• Manufacturer Contact: 8415 154th ave., n.e.; redmond, WA 98052 ; 4255560544
• MDR Report Key: 4589717
• MDR Text Key: 5342185
• Report Number: 3019924-2015-00006
• Device Sequence Number: 1
• Product Code: HOC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: MAL-0002-1
• Device Catalogue Number: MAL-0002-1
• Device Lot Number: 064285
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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