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

Catalog Number 8065752452

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

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 that the tip of the vitrectomy probe broke during a procedure.The broken tip was not retained in the eye.The vitrectomy probe was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

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 seven additional complaints associated with the component lots for the reported issue.One opened probe was received with a tip protector, in a tray, along with a dvd for evaluation.The returned sample was visually inspected and found non-conforming with the probe needle broken at the port and orange/brown foreign material present on the remaining part of the port.The probe was 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.Gouge marks were observed at the bend area and several other locations along the inner cutter.A photo of the product was provided and reviewed by the manufacturing site.The photo confirms that the tip of the probe needle is broken at the port and also shows a trocar cannula/hub assembly on the probe needle.A video on dvd was also received and reviewed by the manufacturing site.The video confirms that tip of probe needle detached during use in the eye.The complaint evaluation confirmed that the probe 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).

• 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: 8912752
• MDR Text Key: 155198178
• Report Number: 1644019-2019-00133
• 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
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 8065752452
• Device Lot Number: 2254002H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM.