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

Catalog Number 8065830048

Device Problem Leak/Splash (1354)

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

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.(b)(4).

Event Description

A surgeon reported two of three valved trocars leaked during a procedure.The third valved trocar did not leak as it had the infusion cannula attached to it.The procedure was completed with product replacement.There was no harm to the patient.This is one of two reports for this surgeon.

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6., and h.10.Two opened 27+ gauge trocar handle/blade assemblies were received for the report of there was leakage from the trocar ports.Sample #1 was visually inspected and found to be conforming.Sample #1 was then functionally tested and was found to be conforming.Sample #2 was visually inspected and was found to be non-conforming with damage to the septum (open slit).The septum was then manipulated to see if the open slit would close.A second visually inspection was then performed and it was noted that the trocar septum still remained opened and was damaged.Leak testing could not be performed due to the damage of the sample.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.Sample #1 was found to be visually and functionally conforming.Sample #2 the exact root cause for this complaint is unknown; the damaged condition of the slit on the septum could have contributed to the reported event; how and when the valve became damaged cannot be determined from the evaluation performed.The exact root cause for this complaint is unknown therefore specific action for this complaint cannot be taken.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.This inspection includes evaluation for damaged valves.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11135779
• MDR Text Key: 226835267
• Report Number: 1644019-2021-00015
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 8065830048
• Device Lot Number: 2318852H
• 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