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

Catalog Number 8065751767

Device Problems Failure to Cut (2587); Detachment of Device or Device Component (2907); Air/Gas in Device (4062)

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

Event Date 10/20/2022

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 physician reported the cutter became detached from the cassette body during the cutting process in the surgery, which subsequently caused cutting defects and air to enter the eye during a vitrectomy surgery.The surgery was completed without product replacement.There was no patient harm.

Manufacturer Narrative

One opened probe was received, with a tip protector, in a tray, for the report of cutter became detached from body, cutting defects and air to enter eye during surgery.The sample was visually inspected and found to be nonconforming with orange/brownish foreign material on the port face.Inspection associated with reported detachment was inadvertently not documented and due to the functional nonconformity the probe was disassembled; therefore, unable to confirm reported detachment.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for cut and aspiration, no bubbles were observed.The sample was found to be non-conforming for actuation.The probe was disassembled and the components inspected.Excessive wear observed on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks observed at several locations along the inner cutter.The sample was retested for actuation with the probe driver and was able to actuate.The initial actuation test failed due to an interference within the probe and once the interference (needle assembly) was removed the probe was able to actuate.A review of the device history record traceable to the lot number obtained from the device¿s rfid (radio frequency identification) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The complaint evaluation was unable to confirm the reported detachment.The complaint evaluation does not confirm the probe had a cut failure and bubbles from port.The evaluation indicates the probe had an actuation failure.The cut functionality of the probe was conforming, however, the observed actuation failure could have caused the probe to not cut at the time the reported event was observed.The root cause for the actuation failure as well as the foreign material observed is due to the excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than 20 minutes and it appears that the probe has experienced a use much greater than this typical timeframe.The excess usage of the probe will wear and damage the inner cutter such that the cutter function becomes poor, bent, or does not function at all.The reported detachment was unable to confirm, the reported bubbles from port and cut failure were not confirmed, and it appears that the observed actuation failure was due to excessive use of the probe by the user; therefore, no specific action with regard to this complaint was taken by the manufacturing site.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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: 15797013
• MDR Text Key: 306518600
• Report Number: 1644019-2022-00944
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657517671
• UDI-Public: 00380657517671
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 8065751767
• Device Lot Number: 2515120H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM