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

Catalog Number 8065751767

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/08/2021

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 gray part of the cutter probe needle was detached and did not come back to the original position during a vitrectomy procedure.The detachment occurred at the insertion to trocar cannula, the needle tip could be inserted into the eye but the needle was pulled out since it was about to be detached.The procedure was completed after the product was replaced.Additional information received from company representative who indicated there was no patient harm.

Manufacturer Narrative

One opened probe was received, without tip protector, in a bubble bag.The sample was visually inspected and found to be nonconforming with the probe needle bent and orange/brownish foreign material on the port face.The inner cutter was observed to bent.Couple gouge marks observed at the bend area and a couple 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 needle is bent, which can be perceived as the probe needle detached.The exact root cause of the bent needle 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 including use during surgery.An exact root cause for the bent needle was not determined from this evaluation, 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: 13222488
• MDR Text Key: 283587734
• Report Number: 1644019-2022-00039
• 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: 03/31/2022

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 Catalogue Number: 8065751767
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1