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

Catalog Number 8065752452

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/02/2020

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 physician reported that the needle of the cutter was loose during surgery.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

Additional information received in d4.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

One opened probe was received with a tip protector, in a tray, along with four unopened probes for the report of loose needle.The returned opened sample was visually inspected and found to be non-conforming with the needle/stiffener assembly separated from the rest of the probe assembly.The opened probe sample was disassembled and the components inspected.No/minimal wear was observed on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.A couple gouge marks were observed along the length of the inner cutter.The four returned unopened samples were visually inspected and all four were found to be conforming.The samples were then functionally tested for actuation to observe if the needle was moving out of the needle/needle holder bond.No needle movement was observed on any of the four unopened samples.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 evaluation confirms the reported issue of a loose needle in the returned opened probe.The evaluation did not confirm a loose needle in the four unopened samples.The root cause for the component detachment in the opened probe is the adhesive bond failure which caused the needle assembly to detach from the rest of the probe assembly.An internal investigation was completed and improvements to the adhesive bond have been identified.A photo of the returned sample has been issued within the learning management system for review with the applicable production personnel to raise awareness of this issue.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed for this reported event.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: 10822842
• MDR Text Key: 217176806
• Report Number: 1644019-2020-00605
• 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: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 8065752452
• Device Lot Number: 2254002H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1