Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 CONSTELLATION 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 CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065751468
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2018
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 the metal tip of the trocar broke during insertion into the sclera during a procedure.The planned procedure was not performed.No information on the status of the patient.
 
Manufacturer Narrative
Three opened trocar blade/handle assemblies were received in a small parts tray for the report of metal tip of trocar blade was broken during insertion.The trocar blade/handle assemblies were returned with not tip protectors.The samples were visually inspected and were found to be nonconforming with damaged tips and damaged cutting edges.A lot number was identified, however is not a valid lot number therefore, lot history and complaint history reviews were not conducted.The photo attached to the parent complaint was reviewed by the manufacturing site.The photo is of three trocar blade/handle assemblies with no tip protectors in a small parts tray.Only one of the trocar assemblies had a trocar hub/cannula assembly.The reported issue of trocar damaged blade can not be confirmed.The exact root cause could not be determined from the investigation performed.The returned samples are visually non-conforming with damaged tips and damaged cutting edges; therefore, a metal tip of the trocar blade was broken during insertion was confirmed; however, how and when the tip of the knives became damaged could not be determined.The exact root cause for the damaged trocar knife samples are unknown, therefore specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformance, such as the damaged tips and damaged cutting edges exhibited on the returned opened samples are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9164232
MDR Text Key182969051
Report Number1644019-2019-00151
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 foreign,other
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065751468
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2019
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-