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

Catalog Number 8065752060

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

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 customer reported the vasectomy probe experienced an actuation failure during a procedure.The condition of the aspiration is not known.The product was replaced 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.The returned sample was visually inspected and was found to be non-conforming with 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 was found non-conforming for aspiration and cut.The probe was disassembled and the components inspected.Excessive 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.The sample was tested with a syringe and resistance was felt.A wire enters the aspiration path but does not go through.The sample was retested with a syringe and resistance was still felt.Solid material was found to be blocking the aspiration path.The coupling was then removed from the extension and foreign material was observed to be blocking the inner diameter of cutter in the coupling.The foreign material identified to be blocking the inner cutter was analyzed and was found to most closely match polycarbonate.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 sample evaluation did not confirm that the probe had an actuation failure.Unrelated to the reported event the evaluation indicated that the probe had aspiration and cut failures.The root cause for the aspiration and cut failures, as well as the observed foreign material, is due to the excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe has experienced a use much greater than this typical timeframe.The excess usage of the probe will wear and damage the inner cutter, decreasing the quality of the cut performed by the probe.Excess usage will also introduce a greater amount of surgical material, increasing the likelihood of partial or full occlusion of the aspiration path.A secondary contributing factor for the observed aspiration non-conformance is shaved plastic in the inner diameter of the coupling which can partially or fully occlude the aspiration path at the cutter/extension interface within the probe.The foreign material analysis identified the particle in the cutter as polycarbonate, which is the same material that the coupling component is composed of.No action in relation to the reported event was taken by the manufacturing site as the returned probe was found to be conforming for actuation.An internal investigation was completed and additional controls within the manufacturing process have been implemented to reduce the frequency of probe complaints for occlusions caused by shaved plastic from the coupling.All probes are 100% visually inspected and 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: 9993215
• MDR Text Key: 188994539
• Report Number: 1644019-2020-00215
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 8065752060
• Device Lot Number: 2328213H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM