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

Catalog Number 8065752451

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

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.(b)(4).

Event Description

A surgeon reported hearing an abnormal sound from a vitrectomy probe and it ceased to cut during a procedure.When he reconnected the vitrectomy probe, it actuated for about 10 seconds but the same issue occurred again.The condition of the aspiration was not known.He replaced the vitrectomy probe with another one and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.One opened probe was received.The sample was visually inspected and found to be non-conforming with the probe needle bent and orange/brown foreign material on the port face.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found to be conforming for actuation and aspiration and was non-conforming for cut.No noise was observed during testing.The sample was then 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.The inner cutter was observed to be bent.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 the reported noise.The evaluation did confirm that the probe had a cut failure.The cause of the cut failure is the observed gouges to the cutting edge of 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.The exact root cause of the bent needle and inner cutter 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.The reported noise was not confirmed and an exact root cause for the cut failure and bent needle and bent inner cutter was not determined from this evaluation, therefore, no specific action with regard to this complaint was taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformances found are removed from the lot and scrapped.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: 10677772
• MDR Text Key: 213257242
• Report Number: 1644019-2020-00553
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 8065752451
• Device Lot Number: 2387324H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM.