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

Catalog Number 8065752439

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

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 physician reported a trocar cannula couldn't be inserted ino the sclera during a vitrectomy surgery.The product was replaced and the surgery was completed.There was no patient harm.

Manufacturer Narrative

Two opened 27+ trocar assemblies and one handle/blade assembly w/tip protector within a tray were received.The samples were visually inspected and were found to be nonconforming with damaged tips and damaged cutting edges.Penetration testing could not be performed due to the damage of the samples.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The exact root cause could not be determined from the investigation performed.The damage to the returned samples is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of dull blade.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformances, such as damaged tips and cutting edges, are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12999818
• MDR Text Key: 282198750
• Report Number: 1644019-2021-00821
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524396
• UDI-Public: 00380657524396
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 8065752439
• Device Lot Number: 2421800H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1