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

Lot Number 139829

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2023

Event Type  malfunction  

Event Description

Retractor failed to open properly.

• Brand Name: MALYUGIN RING RETRACTOR
• Type of Device: CLIP, IRIS RETRACTOR
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.
• MDR Report Key: 17109426
• MDR Text Key: 317127665
• Report Number: MW5118329
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 139829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White