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

Catalog Number 8065751908

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2019

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 doctor reported that the probe could not be removed from the eye, unless it was removed with trocar cannula during a procedure.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

No sample has been returned for evaluation for the report of could not be removed unless with trocar; therefore, the condition of the product could not be verified.A photo of the products is attached to the parent file and has been reviewed by the manufacturing site.The photo shows the trocar cannula assembly on the probe needle.The physical state of the probe cannot be determined from the photo.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 complaint history examination indicates there is one additional complaint associated with the lot for the reported issue.A sample was not returned 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 as no sample was returned; therefore, specific action with regards to this complaint cannot be taken.All probes and trocar assemblies are 100% visually inspected and probes tested during manufacturing.Any non-conformances found are removed from the lot and scrapped.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

One opened probe with tubing attached and a trocar hub/cannula assembly on the tip of the probe with tape around it, were received in a tray for the report of cutter cannot be removed out of eye unless removed with trocar cannula.The trocar sample was visually inspected and was found non-conforming with dried foreign material on and in the trocar cannula.The cannula was cleaned prior to dimensional and functional testing.The sample was then dimensionally inspected for cannula inner diameter and was found conforming.A functional fit test with the probe was then performed and was found to be conforming.The returned sample was found to be conforming, the evaluation confirms the probe had a product fit issue.The fit issue was due to the foreign material on the needle.The exact source of the foreign material cannot be determined from this evaluation; however the most likely contributing factor is surgical residue from use and does not point to a manufacturing issue due to the foreign material easily wiping off with alcohol.No action was taken as the trocar and probe were manufactured to specifications.All trocar and probe assemblies are 100% inspected.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.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: 8545238
• MDR Text Key: 143038951
• Report Number: 1644019-2019-00061
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 8065751908
• Device Lot Number: 2177662H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1