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

Catalog Number 8065751077

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 04/09/2021

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 nurse reported the trocar separated from the metal tube during a vitrectomy procedure.The procedure was completed after a new replacement was used.There was no harm to the patient.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.The product was processed and released according to the product¿s acceptance criteria.Because a sample was not received at the manufacturing site and the product was processed and released according to the product¿s acceptance criteria, the exact root cause for this complaint is unknown.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is 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).

Manufacturer Narrative

Correction in previous manufacturing device report was related to h.6.Not h.10.A product sample has been received by the manufacturer and it is awaiting evaluation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Two opened 23 gauge (ga) trocar hub and cannula in bag inside a tray were received.The returned trocar cannula/hub samples were visually inspected and were found to be non-conforming, the hub and cannula were separated.There was presence of adhesive inside of the hub.During assembly of the trocar product adhesive is dispensed at the cannula hub interface.The evaluation of the returned samples identified adhesive inside of the hub, therefore, how and when the trocar cannula and hub became separated cannot be determined from this evaluation and the root cause for this complaint is unknown.A potential contributing factor of the separation is manipulation during surgery.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Assemblies are 100% inspected for adhesive application during assembly.If adhesive application is incorrect the assembly is 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
• MDR Report Key: 11671754
• MDR Text Key: 247712487
• Report Number: 1644019-2021-00259
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657510771
• UDI-Public: 00380657510771
• 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,Followup
• Report Date: 10/26/2021

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: 07/31/2022
• Device Catalogue Number: 8065751077
• Device Lot Number: 2402945H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 09/13/2021; 10/05/2021
• Supplement Dates FDA Received: 07/09/2021; 09/14/2021; 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1