• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752182
Device Problem Output Problem (3005)
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that an aspiration failure occurred during ultrasound.The surgery was completed after replacing the product with another one.There's no patient harm.
 
Manufacturer Narrative
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.Two used samples were returned for evaluation.Inspection of the sample found no obvious defects that would have contributed to the reported event.The fms (fluidics management system) cassette was tested on a console, primed and tuned with the ultrasonic hand piece successfully and could achieve maximum vacuum.No system message was generated during functional testing.No fluid or air leaks, and no cracks were observed from the connectors.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the bss (balanced salt solution) bottle through the irrigation path continuously, no fluidic anomalies were observed.No occlusion or obstruction was identified during inspection and functional testing.The root cause of the customer's complaint could not be established as the returned fms cassette was evaluated and met specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CENTURION 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 Key11012255
MDR Text Key222014959
Report Number1644019-2020-00688
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Catalogue Number8065752182
Device Lot Number2323340H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Date Manufacturer Received03/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-