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 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.(b)(4).

Event Description

A customer reported that the tip of the cutter, which was used multiple times, was broken during use.The broken tip was removed within the same session.The cutter was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

The returned sample was visually inspected and found non-conforming with the probe needle broken at 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 cutting edge and a couple locations along the inner cutter.No lot number was identified with this complaint; however, a review of the device history records traceable to the lot number obtained from the customer returned device¿s rfid tag indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirmed that the probe had a broken tip at the port.Per the reported complaint description the probe was used multiple times and the customer recognized the improper use of the device.Therefore, the root cause of the broken tip is use error due to the directions for use (dfu) not being properly followed for the single use device.An internal investigation has been completed to further evaluate the cause of probe tip breakage at the port.No additional action has been taken by the manufacturing site as it appears that the broken port was due to the dfu not being properly followed by the user and the device being used multiple times.All probes are 100% visually inspected for tip defects.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: 9720790
• MDR Text Key: 183516783
• Report Number: 1644019-2020-00091
• 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: 04/28/2020

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 Catalogue Number: 8065752452
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM