• 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, LTD. - 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, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number ASKU
Device Problems Fitting Problem (2183); Material Integrity Problem (2978)
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. (b)(4).
 
Event Description
A healthcare professional reported that on four occasions the hydro dissection cannula does not always fit through the trocar cannula. It was noted that the trocar also came out of the patients eyes while trying to remove the cannula. There was no harm to patients. Patient identifiers are not expected. Additional information has been requested and received.
 
Manufacturer Narrative
No sample has been returned for evaluation for the report of trocar pulled out; therefore, the condition of the product could not be verified. No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted. A sample was not returned and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined. Since no lot or contract number was received, no further investigation of the dhr could be performed. Also no item number or further information on the item was received. There is no complaint sample or picture available for further investigation. As no contract, no lot and no sample is available, no investigation to the actual root cause is possible. The most probable root cause is supplier related. Cannulas and needles are received by the supplier in a protective hub and/or blister and added as such to the custom pak. No additional inspection or handling is performed during the manufacturing process of the custom paks. Therefore the operators are unable to see and check this type of defect. The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCONSTELLATION SURGICAL PROCEDURE PAK
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
MDR Report Key7734916
MDR Text Key115648536
Report Number1644019-2018-00193
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
Type of Report Initial,Followup
Report Date 09/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/31/2018 Patient Sequence Number: 1
Treatment
CUSTOM PAK; TROCAR ENTRY SYSTEM
-
-