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

Catalog Number 8065751903

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Retinal Detachment (2047)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted.No anomalies were identified.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 returned for evaluation; therefore, the condition of the product could not be verified.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.No specific action with regard to this complaint was taken by the manufacturing facility because no complaint sample was received to determine a root cause.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.(b)(4).

Event Description

A healthcare professional reported by medwatch form to the regulatory agency that during a procedure, "the vitrector became stuck on the cannula and would not come off.The vitreous cutter became adherent to the cannula and could not be removed.Impact: a temporal tear with bridging vessel and with small localized retinal detachment was present.Nasal periphery was inspected and a large tear was identified at 3 and a smaller tear at 4 with retinal detachment from 3-6 with evidence of vitreous incarceration." additional information and product sample have been requested.

Manufacturer Narrative

(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: 5703712
• MDR Text Key: 46723227
• Report Number: 1644019-2016-00878
• 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: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 8065751903
• Device Lot Number: 1848233H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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