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)

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

Event Type  malfunction  

Event Description

A physician reported cutting failure of the vitrector probe occurred during cataract/ vitrectomy combination procedure.Cutter probe which was detached from the cassette was the reported probe.The condition of aspiration and actuation was unknown.The procedure was completed after replacing the product with another one.There was no patient harm.

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).

Manufacturer Narrative

One opened probe was received, without a tip protector, in a tray with other items.The sample was visually inspected and found to be conforming.The sample was then functionally tested for actuation and cut.The sample was found to be conforming for actuation and nonconforming for cut.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 cutting edge and several other locations along the inner cutter.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The complaint evaluation confirms the probe had a cut failure.The cause of the cut failure is the observed gouge marks on the cutting edge of the inner cutter of the probe.The root cause of the gouge marks observed on the cutting edge is due to the excessive surgical use of the probe.The vitrectomy portion of the procedure is typically less than twenty 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.No action has been taken by the manufacturing site as it appears that the observed cut failure was due to excessive use of the probe by the user.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: 15410039
• MDR Text Key: 300664151
• Report Number: 1644019-2022-00738
• 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: 12/07/2022

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: 10/31/2023
• Device Catalogue Number: 8065751767
• Device Lot Number: 2535216H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM