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

Catalog Number ASKU

Device Problems Appropriate Term/Code Not Available (3191); Device Fell (4014)

Patient Problems Purulent Discharge (1812); Endophthalmitis (1835)

Event Date 05/24/2019

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 customer indicated that the hoses fell on the table, which was properly covered with sterile fields for the surgical procedure.Immediately, the surgery staff proceeded to change hoses and the surgery was completed without complication.However, the following day, after the routine revision of the patient, a diagnosis of purulent endophthalmitis was found, so it was necessary to perform vitrectomy with intravitreal antibiotics.Subsequently, a culture was performed, which had negative result for growth of pathogenic germs.

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.All lots are 100% visually inspected and every lot is verified that all required tests have been performed and all acceptance criteria were met.All constellation procedure packs are single-use devices provided to the customer in a sterile manner.The root cause of the customer's complaint could not be established as a sample has not been received and therefore the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.All centurion procedure packs are single-use devices provided to the customer in a sterile manner.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8716772
• MDR Text Key: 148567199
• Report Number: 1644019-2019-00104
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK.; CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Required Intervention