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

Catalog Number 8065751912

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

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

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

A sample has been received by a company representative.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.A non-safety medical device correction was completed on (b)(6) 2015 and a manufacturing change implemented to address the root cause.All potentially impacted alcon customers have been contacted, trocar plugs made available and other risk mitigations discussed.Attempts have been made to obtain additional information.No further information is expected.(b)(4).

Event Description

A theatre manager reported that during a vitreoretinal surgery, the 23g trocar was noted to be leaking.Once the vitrectomy and lens implant explantation had been completed the eye suddenly lost pressure and the eyeball completely collapsed.The eyeball collapse led to the infusion 23g trocar being displaced and 360 choroidals instantly developed.The infusion eye pressure remained zero for at least one minute as the system was not correctly adjusting or controlling the intraocular pressure through the infusion line.Despite eye re-inflation and attempts to drain the choroidals, the choroidals were not resolved.It was decided that it was unsafe to implant a secondary lens implant and the patient's eye was closed.It was disclosed on the incident form that these trocars had been leaking for several months.The patient's symptoms were improving at the moment of this report.The patient will require further surgery once the eye has settled to implant an intraocular lens.Additional information received from the (b)(6).They expect the patient to make a full recovery and there would be no long term harm.Attempts have been made to obtain additional information.No further information is expected.This is one of eight reports being filed for the same facility.This report is for the event occurred on (b)(6) 2016.

Manufacturer Narrative

Evaluation summary: three opened 23 ga trocar cannula/hub assemblies taped to paper were received for the report of leaking.The returned samples were visually inspected.Sample 1 was found to be nonconforming with a hole in the septum and samples 2 and 3 were found to be conforming.Samples 2 and 3 were then functionally tested for leaking.Sample 2 was found to be conforming and sample 3 was found to be nonconforming.For this complaint file, the final customer two lot numbers were identified.For these final lots, eight 23 ga valve entry component lots were used to make up the final lots.A device history record review for each of the component lots was conducted.According to the device history record reviews, three lots were reprocessed for an anomaly that did not contribute to the customer complaint.The device history record reviews did not point to a root cause because the lots were reprocessed and the product was released in accordance with all product acceptance criteria.Five lots had no anomalies found based on the device history record reviews.Due to an observed increased trend for this defect mode, a manufacturing root cause investigation was initiated to investigate the increased trend and identify corrective and preventive actions.The root cause for the increased complaint rate for leaking trocars was correlated to a manufacturing post assembly inspection practice that required manipulation of the valved septum along the blade shaft.This complaint reported lot includes affected manufacturing lots.

• 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: 5491576
• MDR Text Key: 40023786
• Report Number: 1644019-2016-00497
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065751912
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: CASSETTE
• Patient Outcome(s): Other; Required Intervention