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

Catalog Number 8065752015

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

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 surgeon reported two vitrectomy probes did not actuate during a vitrectomy phrase of a cataract/vitrectomy procedure of a patient.A third vitrectomy probe was obtained and the procedure was completed.The condition of the aspiration was not known.There was no harm to the patient.This file is for the first vitrectomy probe.

Manufacturer Narrative

One opened probe was received.The returned sample was visually inspected and found to be non-conforming.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for aspiration and cut and was non-conforming for actuation.The probe was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks were observed at a couple locations along the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle and shell assembly) was removed the probe was able to actuate.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirmed that the probe had a an actuation failure.The most likely cause for the actuation failure is the observed damage/wear to the inner cutter of the probe.A damaged/worn inner cutter can impede the movement of the cutter shaft.How and when the inner cutter of the probe became damaged/worn cannot be determined form this evaluation.No specific action with regard to this complaint was taken by the manufacturing site because the exact root cause for the actuation failure cannot be determined from this evaluation.All probes are 100% tested for actuation, aspiration, and cut during manufacturing.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: 10143221
• MDR Text Key: 195538415
• Report Number: 1644019-2020-00282
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 8065752015
• Device Lot Number: 2278261H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM