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

Model Number MAL-0001-1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

The surgeon reported that three malyugin rings came apart during removal from the eye.There was no impact to the patient.

• Brand Name: MALYUGIN RING SYSTEM
• Type of Device: IRIS CLIP RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; redmond WA
• Manufacturer Contact: 8415 154th ave., ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 4645917
• MDR Text Key: 5753438
• Report Number: 3019924-2015-00007
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• 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: 05/01/2017
• Device Model Number: MAL-0001-1
• Device Catalogue Number: MAL-0001-1
• Device Lot Number: 060233
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other