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

Catalog Number 8065752438

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 moved forward from the probe during a procedure.The surgeon indicated probe just lengthen while cutting.The product was replaced with another and the procedure was completed.There was no harm to the patient.This is one of two reports for this facility.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.Ten unopened probes were received with tip protectors, in trays along with other unused items, for the report of probe lengthened while cutting.A sampling of four samples were visually inspected for loose needles only and all four samples were found to be conforming with no loose needles observed.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 samples evaluated were found to be conforming, therefore the customer complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the probes evaluated were manufactured according to specification.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.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: 10270517
• MDR Text Key: 199687788
• Report Number: 1644019-2020-00363
• 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
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PIK PAK (DC-ELK)