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

Catalog Number 8065752450

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

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 physician reported the outer cylinder of the cutter extended and touched the detached, fluffy, floating retina during surgery to repair a retinal detachment.The cutter was replaced but it failed to pass the test.The surgery was completed with a third cutter.There was no patient harm.

Manufacturer Narrative

One opened probe was received, without tip protector, in a tray along with other items.At the time of receipt, the needle/stiffener was in a pouch and inner cutter was observed to be bent.The sample was visually inspected and found to be nonconforming with the probe needle/stiffener pulled out of the needle holder, confirming the received condition.Orange/brownish foreign material on the port face.Nominal wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.The inner cutter was observed to be severely bent.Gouge marks observed at one location on the inner cutter.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The complaint evaluation confirms a needle/stiffener assembly detachment, which can be perceived as the outer cylinder of cutter extended.The root cause for the component detachment is the adhesive bond failure which caused the needle assembly to detach from the rest of the probe assembly.Unrelated to the reported event the evaluation found the inner cutter severely bent.How and when the inner cutter became bent cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site including use during surgery.An internal investigation was completed and improvements to the adhesive bond have been identified.No additional actions has been taken by the manufacturing site as the exact root cause for the bent inner cutter could not be determines from this evaluation.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.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12884039
• MDR Text Key: 281346163
• Report Number: 1644019-2021-00757
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524501
• UDI-Public: 00380657524501
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 8065752450
• Device Lot Number: 2468200H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1