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

Catalog Number ASKU

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary.A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice.This complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection.The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically.(b)(4).

Event Description

An ophthalmic surgeon reported that at least one of the three valved trocars leaked upon insertion in over fifty percent of the vitrectomy procedures for retinal detachments.In instances where the patient was already vitrectomized and there was gas or liquid present in the eye, one might get leakage immediately."often the liquid squirts up toward the biomicroscope lens (biom) lens in one squirt".In addition, "when one switches to air and must e.G.Laser treat in air then it bubbles with air around the laser cable and up under the biom lens which means that one must continuously stop and clean up under the lens".There is no known harm to the patients.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the surgeon.The surgeon indicated in some cases, the leakages were observed as soon as the procedures were started, while in other procedures, leakage occurred after a period of time.In most of the procedures, the leakage was from multiple trocars.The trocars were replaced in a majority of the cases and all the procedure were completed with no harm to the patients.

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6144130
• MDR Text Key: 61706222
• Report Number: 1644019-2016-01495
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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