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

Catalog Number 8065752450

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/24/2019

Event Type  Injury  

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 that the top of the probe broke during a procedure.The broken part was discovered in the patient's eye once, but it would not be found.The procedure was completed after replacing the probe and with no reported harm.After the procedure, a ct was taken and the broken part was found to be retained in the patient's eye.The broken part was removed from the eye in the reoperation on the day.

Manufacturer Narrative

A product sample was received and it is awaiting evaluation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Three opened probes were received for evaluation.Sample # 1 was visually inspected and found to ne non-conforming with the tip broken at the port.Sample # 2 was visually inspected and found to be conforming.Sample # 3 was visually inspected and found to be conforming.Sample # 1 was then disassembled and the components inspected.Nominal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Orange/brown foreign material was observed on several locations along the id of the inner cutter.Gouge marks were observed at the bend area, cutting edge and several other locations along the inner cutter.A usb with two videos was also provided and reviewed by the manufacturing site.The videos confirm that the probe tip was broken during surgery.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 complaint history examination for device component lots traceable to the reported lot number indicates there are two additional complaints associated with the component lots for the reported issue.The complaint evaluation confirmed that one of the returned probes had a broken tip at the port.The exact root cause for the broken tip cannot be determined from this evaluation.An internal investigation has been completed to further evaluate the cause of probe tip breakage at the port.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will continue to be reviewed and closely 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).

Manufacturer Narrative

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

Event Description

Additional information was received.Ct scan was performed again after the reoperation and it was confirmed that no broken tip remained.No abnormality was noted for the patient.

• 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: 8773300
• MDR Text Key: 150472745
• Report Number: 1644019-2019-00109
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 8065752450
• Device Lot Number: 2118286H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR