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

Catalog Number 8065752438

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

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 nurse reported the outer sheathing of the vitrectomy probe became disconnected from the probe during a procedure.The surgeon was able to retract the probe from the eye successfully and there was no harm to the patient.The product was replaced with another and the procedure was completed.This is one of two reports for this facility.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.6., and h.10.A sample was not received at the manufacturing site for evaluation therefore, the condition of the product could not be verified.Photos of the product and pak label are attached to the parent file and have been reviewed by the manufacturing site.The photo of the product confirms that the needle assembly has pulled out of the needle holder.The photo of the pak label shows product and lot information that matches what was reported.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.A sample was not received at the manufacturing site, however, the attached customer product photo confirms the reported issue of outer sheathing of the probe disconnected.The exact root cause of the component detachment cannot be determined.An internal investigation has been initiated in order to investigate the component separation.All 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 PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10273554
• MDR Text Key: 199475177
• Report Number: 1644019-2020-00369
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 8065752438
• Device Lot Number: 2360282H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 09/25/2020
• Supplement Dates FDA Received: 07/31/2020; 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PIK PAK (DC-ELK)