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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065751910
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/17/2018
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
An ophthalmic surgeon reported that during multiple procedures they experience leakage from the valved trocars.It was noted that at the beginning of the case it is like a dribble and after the instrument exchange it start like a spray.Additional information was requested.
 
Manufacturer Narrative
No sample has been returned for evaluation for the report of leaking trocar; therefore, the condition of the product could not be verified.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.A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue.No sample was returned and the device history record review of the lot number provided indicated product was processed and released according to the product¿s acceptance criteria, therefore the root cause for the defect experienced by the customer cannot be determined.The exact root cause for this complaint is unknown.Investigations have been completed and manufacturing process enhancements are presently being implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No additional action is required at this time.(b)(4).
 
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Brand Name
CONSTELLATION SURGICAL PROCEDURE PAK
Type of Device
GENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7346526
MDR Text Key102857520
Report Number1644019-2018-00055
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue Number8065751910
Device Lot Number2105116H
Other Device ID Number380657519101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/17/2018
Initial Date FDA Received03/16/2018
Supplement Dates Manufacturer Received03/20/2018
Supplement Dates FDA Received03/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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