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

Catalog Number 8065751910

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2020

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 that the vitrectomy probe tip was difficult to remove from the eye because it seemed to be bent.The product was replaced and the procedure was completed.Patient impact is unknown.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received.The procedure was completed without patient harm.

Manufacturer Narrative

Additional information provided in h.3, h.6 and h.10.A sample was not received at the manufacturing site for evaluation; 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 during the manufacturing process for excessive manufacturing materials on the needle.All assembled probe needle diameters are also 100% tested for fit into a ring gauge to insure the probe needle does not exceed a trocar opening.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: 10253385
• MDR Text Key: 199093236
• Report Number: 1644019-2020-00357
• 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: 09/24/2020

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: 02/28/2022
• Device Catalogue Number: 8065751910
• Device Lot Number: 2369335H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 08/11/2020; 09/16/2020
• Supplement Dates FDA Received: 08/31/2020; 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1