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

Catalog Number 8065830029

Device Problems Decrease in Suction (1146); Loss of Power (1475); Noise, Audible (3273)

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

Event Date 12/23/2020

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 hearing a strange sound while using the cutter (vitrectomy probe), and the cutting sometimes stopped suddenly and aspiration felt weaker during a procedure.This occurred to three packs during one procedure.The procedure was completed after replacing with the fourth pack.There was no harm to the patient.This report is for one of four reports from this facility.

Manufacturer Narrative

One opened probe was received.The returned sample was visually inspected and found to be non-conforming with black foreign material on the port face.The sample was then functionally tested for actuation, aspiration and cut.The sample was found conforming for actuation and aspiration, with no noise observed during testing, and was non-conforming for cut.The probe was disassembled and the components inspected.Nominal 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 the cutting edge and several other locations along the inner cutter.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 did not confirm a strange noise or weak aspiration within the returned probe.The evaluation did confirm that the probe had a cut failure.The root cause for the cut failure is the gouge marks on the cutting edge of the inner cutter of the probe.A damaged cutting edge can decrease the quality of the cut performed by the probe.How and when the cutting edge of the inner cutter of the probe became damaged cannot be determined form this evaluation.No specific action with regard to this complaint was taken by the manufacturing site because the reported noise and aspiration failure were not confirmed and the exact root cause for the cut issue 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 PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11151439
• MDR Text Key: 227575048
• Report Number: 1644019-2021-00025
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 8065830029
• Device Lot Number: 2258417H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM.