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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 ASKU
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
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.(b)(4).
 
Event Description
A customer reported that the surgeon could not move the laser probe within the trocar.The surgeon was able to get the probe into the trocar but it did not maneuver well and when the probe was removed the trocar came out with it.The procedure was completed without patient harm.
 
Manufacturer Narrative
No sample has been returned for evaluation for the report of trocar came out with probe; 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.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.No additional action is required at this time.The manufacturer internal reference number is: (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
MDR Report Key7674850
MDR Text Key113801758
Report Number1644019-2018-00163
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 other
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/25/2018
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 Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/13/2018
Initial Date FDA Received07/10/2018
Supplement Dates Manufacturer Received08/31/2018
Supplement Dates FDA Received09/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
25GA ILLUMINATION FLEXIBLE CURVE LASER PROBE
Patient Outcome(s) Other;
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