MAUDE Adverse Event Report: MEDONE SURGICAL, INC. MEDONE SURGICAL, INC.; OPHTHALMIC CANNULA

Lot Number J1425

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/05/2015

Event Type  malfunction  

Event Description

Tip detached from cannula during surgery.Cannula was being used for fluid extraction during vitrectomy procedure.During the case, the surgeon noticed that the clear flex tip detached from the cannula.Surgeon's fellow was able to grasp the flex tip with forceps and attempted to pull it out thru 25g cannula.Flex tip was not present on forceps once outside the eye.Surgeon performed additional examinations of posterior chamber of eye but was unable to visualize the flex tip and aborted the search.No patient injury was reported.

Manufacturer Narrative

The device in question was requested for our investigation but was not returned.All devices from this lot were distributed (last date of distribution of this lot was 01/14/2015) with no other complaints reported for this lot number nor any similar complaints ever reported for this product number in the past ten years.There was no patient injury reported.

• Brand Name: MEDONE SURGICAL, INC.
• Type of Device: OPHTHALMIC CANNULA
• Manufacturer (Section D): MEDONE SURGICAL, INC.; 670 tallevast road; sarasota FL 34243
• Manufacturer Contact: bruce beckstein ; 670 tallevast road; sarasota, FL 34243 ; 8666336631
• MDR Report Key: 4602794
• MDR Text Key: 5465142
• Report Number: 1064371-2015-00001
• Device Sequence Number: 1
• Product Code: NGY
• 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: Other
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Lot Number: J1425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2014
• 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