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

Catalog Number 8065751765

Device Problem Difficult to Remove (1528)

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

Event Date 11/02/2022

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 trocar adhering to the instruments and not allowing the usual vitrectomy procedure.The procedure details and the patient impact was not reported.Additional information was requested.However, none has been received till date.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6.And h.10.Two opened trocar assemblies and four open trocar handle blade assemblies in a bag were received.Samples #1, #2, #3 and #4 were visually inspected and found to be nonconforming, the cannula/hub assemblies were missing from the handle blade assemblies, therefore the cannula/hub assemblies could not be dimensionally inspected.Samples #5 and #6 were visually and dimensionally inspected and were found to be conforming.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 returned samples #5 and #6 were found to be conforming, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.Samples #1, #2, #3 and #4 were missing the cannula/hub assemblies and could not be visually or dimensionally tested, therefore the root cause could not be determined.No action was taken as the trocar samples #5 and 6 were manufactured to specifications and samples #1, #2, #3 and #4 were missing the trocar cannula/hub assemblies.All trocar assemblies are 100% inspected for gage size.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 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: 15801632
• MDR Text Key: 305377969
• Report Number: 1644019-2022-00947
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657517657
• UDI-Public: 00380657517657
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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: 09/30/2023
• Device Catalogue Number: 8065751765
• Device Lot Number: 2525823H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1