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

Catalog Number MAL-1002-1

Device Problem Firing Problem (4011)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Event Description

Malyugin ring did not deploy correctly prior to insertion.No patient contact or patient information known at this time.

• Brand Name: MST MALYUGIN RING
• Type of Device: CLIP, IRIS RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC.; redmond WA 98052
• MDR Report Key: 8311471
• MDR Text Key: 135936004
• Report Number: MW5083758
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: MAL-1002-1
• Device Lot Number: 105094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1