MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that 2 patients have presented postoperatively with an ocular infection following a surgical procedure in which the staff needed to use an external gas cylinder or gas pak.Additional information has been requested.

Manufacturer Narrative

The customer reported ¿two cases of post infection after using a vision system which included the use of the gas pak for injection of sf6.The concern she has is with an issue (with their sf6 cylinder attached to the back of the system.) the customer states that ¿when they went to take gas, the cylinder was empty and they were left with the choice to use the external gas cylinder or use the c3f8 gas with a gas pak.The company representative has been made aware of this issue.¿ the surgeon is concerned that somehow the bacteria has come from somewhere in the gas pathway, because this obviously had a leak.The hospital has ¿isolated the bacteria¿ and having running tests, currently.There has been no additional information provided on the results found by the hospital at this time.The vision system has an auto gas fill option that is used to fill a syringe with a specified gas (either c3f8 or sf6).The c3f8 (red) and the sf6 (blue) gas bottles must be connected per the color-coding scheme indicated in the operator¿s manual.The c3f8 and sf6 must be used with the red and blue connector respectively.The user is required to make the appropriate selection of gas before proceeding.The operator¿s manual states: ¿the gas mix ratio guide is a tool to assist the user in calculating the syringe volume adjustments required in order to achieve the desired mixture.Note: ¿adjusting the gas mix ratio guide does not automatically fill the syringe to the desired mixture.The user must manually move the plunger to make the gas volume adjustment in the syringe after detaching the syringe assembly from the console.¿ to achieve a specific gas/air mix ratio (after the system has purged then filled the syringe with 20cc of gas), use the gas mix ratio guide as follows: move the slider on the guide to the desired percent of gas mixture.The guide displays the syringe reading that the plunger must be moved to in order to achieve the displayed percentage of gas in the syringe (18% -> 10.8 cc in the auto gas fill popup).For an 18% gas mixture, push the plunger from 20cc to 10.8cc.Then pull the plunger out to 60cc.The resulting mixture will be 18% of the selected gas.To assess whether performing an air or gas exchange at the conclusion of a microincision vitrectomy procedure is beneficial regarding the rate of endophthalmitis.This was a collaborative, multicenter, retrospective chart review of 2,336 eyes that underwent microincision sutureless vitrectomy (23 or 25 gauge) with either sf6 or c3f8 gas endotamponade for macular hole between january 2008 and december 2009.For all eyes, the search methodology was structured to identify the main outcome measure, which was the occurrence of acute postoperative endophthalmitis (<6 weeks after pars plana vitrectomy).Of the cumulative 2,336 consecutive cases over a 2-year period, only 1 (0.04%) had postoperative endophthalmitis.All eyes had near-complete gas-fluid exchange at the end of surgery; c3f8 was the most common endotamponade agent.The majority of cases were performed with 23-gauge vitrectomy.No other complications were noted.Endophthalmitis was a rare occurrence in this large series of gas-filled eyes after macular hole surgery (0.04%).Gas endotamponade after microincision sutureless vitrectomy may be beneficial in reducing the risk of postoperative endophthalmitis; however, additional studies are necessary to make a definitive recommendation.The company service representative examined the system and replicated the reported leaking event.The company service representative observed a leak in the pneumatic module.The pneumatic module was replaced to resolve the issue.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a leaking pneumatic module.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided in d.4.And h.4.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8871400
• MDR Text Key: 153595818
• Report Number: 2028159-2019-01449
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

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 Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 08/12/2019; 09/18/2019
• Supplement Dates FDA Received: 08/13/2019; 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other