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

Catalog Number 8065751077

Device Problems Failure to Cut (2587); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

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 that the probe did not cut during a procedure.Aspiration was functional.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of not cutting; therefore, the condition of the product could not be verified.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.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.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.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.One opened probe was received with a tip protector, in a plastic bag, for the report of could not cut or aspirate.The returned sample was visually inspected and found to be non-conforming with the cutter in the port of the needle and foreign material in the port and along the needle.The sample was then functionally tested for actuation, aspiration, and cut.The sample was found non-conforming for actuation and aspiration with the inner cutter remaining in the port of the needle during testing.The cut functionality of the returned probe was unable to be tested due to the actuation failure.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.The inner cutter pulled out of the coupling.Presence of adhesive was observed on the inner cutter.The inner cutter / coupling adhesive bond fillet was visually inspected and found to be non-conforming.Gouge marks and wear marks were observed at a couple locations along the inner cutter.The evaluation indicated that the returned probe sample had actuation and aspiration failures.The cut functionality of the returned probe was unable to be tested due to the observed actuation failure.However, actuation failure would have cause the probe to not perform the cut, as was reported.The cause of the aspiration failure is the inner cutter remaining in the port due to the actuation failure, obstructing aspiration flow through the inner cutter.The root cause for the observed actuation failure is the separation of components within the probe.It appears that at the beginning of surgical use the adhesive bond failed causing the inner cutter to detach from the coupling.An investigation has been completed and actions have been implemented to lower the frequency of probe complaints due to the detachment of the inner cutter from the coupling.The procedure has been reviewed and was found to provide adequate instructions to operators for the bonding process of the inner cutter to coupling.The inner cutter / coupling adhesive bond fillet for the returned sample was non-conforming.Therefore, an investigation photo of the returned sample has been issued within the learning management system for review with the applicable production personnel to raise awareness of this issue.Probe assemblies 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.No additional action is required at this time.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: 9785431
• MDR Text Key: 185011300
• Report Number: 1644019-2020-00122
• 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,Followup
• Report Date: 07/21/2020

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: 02/28/2021
• Device Catalogue Number: 8065751077
• Device Lot Number: 2260405H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 05/06/2020; 07/08/2020
• Supplement Dates FDA Received: 05/19/2020; 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM XT