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

Catalog Number 8065830029

Device Problems Decrease in Suction (1146); No Device Output (1435); Noise, Audible (3273)

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

Event Date 12/23/2020

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 surgeon reported hearing a strange sound while using the cutter (vitrectomy probe), and the cutting sometimes stopped suddenly and aspiration felt weaker during a procedure.This occurred to three packs during one procedure.The procedure was completed after replacing with the fourth pack.There was no harm to the patient.This report is for one of four reports from this facility.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6., and h.10.Two opened probes were received.At the time of receipt it was observed that the probe without the tip protector was bent at the stiffener.Sample #1 was visually inspected and found to be non-conforming with orange/brown foreign material on the port face.The sample was then functionally tested for actuation, aspiration, and cut and was found to be conforming for all three tests with no noise observed.Sample #2 was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and the probe needle and inner cutter bent and cracked, confirming the received condition of the probe.Functional testing, disassembly activities, and a wear evaluation were unable to be performed due to the visual condition of the probe.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.The complaint evaluation indicated that sample #1 was functionally conforming with no noise observed.Sample #2 was received with the needle and cutter bent and cracked.Therefore, a confirmation of the reported event could not be determined and the exact root cause of the complaint could not be verified.The exact root cause of the bent and cracked needle and cutter cannot be determined from this evaluation.The most likely root cause is handling at any point after the probe was shipped from the manufacturing site.Confirmation of the reported event could not be determined and an exact root cause for the bent/cracked needle could not be verified, therefore, no specific action with regard to this complaint was taken.Probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-conformance's found are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11151258
• MDR Text Key: 229613524
• Report Number: 1644019-2021-00026
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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: 02/28/2021
• Device Catalogue Number: 8065830029
• Device Lot Number: 2256158H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM