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 06/17/2021

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 one of the three trocar was hard to spike (put in) during a procedure.The product was replaced and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

One opened 27+ trocar assembly and two handle/blade assemblies with caps in a tray were received for the report.The samples were visually inspected and were found to be non-conforming.Sample #1 trocar blade was found with a damaged tip and a damaged cutting edge.Samples #2 and #3 the trocar blades had damaged tips and were missing the cannula/hub assembly.Penetration testing could not be performed due to the damage of the sample.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 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 sample could have contributed to the customers reported issue of dull blade.Samples #2 and 3 also were missing the cannula/hub assembly, since the handle blades were returned open how and when the cannula/hub assemblies became missing could not be determined from the investigation performed.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 non-conformances, such as damaged tip and damaged cutting edge, are removed from the lot and scrapped.The exact root cause for the missing cannula/hub on samples #2 and #3 is unknown therefore specific action for this complaint cannot be taken, all trocar assemblies are 100% inspected for trocar hub/cannula assemblies by vision detection during the automated assembly process.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
• MDR Report Key: 12048024
• MDR Text Key: 257714270
• Report Number: 1644019-2021-00413
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524396
• UDI-Public: 00380657524396
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 8065752439
• Device Lot Number: 2368450H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1