MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751613

Device Problem Mechanical Jam (2983)

Patient Problem Retinal Detachment (2047)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported that the vitrectomy probe became stuck in the trocar during a vitrectomy procedure.The issue was resolved by holding the trocar in place to remove the probe.The patient experienced a retinal detachment.Additional information and product sample have been requested; however, no further information has been received to date.

Manufacturer Narrative

A device history record (dhr) review was conducted; no anomaly was found during the dhr review.The product was released based on the product¿s acceptance criteria.A complaint lot history examination indicates there were no other complaints for the reported issue.No sample was received for evaluation; therefore visual and functional testing could not be conducted.Because a sample was not returned and the lot information indicates the product was released based on the product¿s acceptance criteria, the root cause for the customer complaint issue cannot be determined.Based on the complaint information, the technique when pulling out the probe may have been a contributing factor.Quality assurance will continue to monitor customer complaints and will take action for any future occurrences as is deemed necessary.(b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5354436
• MDR Text Key: 35458463
• Report Number: 1644019-2016-00023
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 8065751613
• Device Lot Number: 1783298H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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