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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065752450
Device Problems Vibration (1674); Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2022
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 physician reported actuation failure of the probe occurred and the cutter made a strange noise while in use during surgery.The condition of aspiration is unknown.The product was replaced and the surgery was completed.There was no patient harm.
 
Manufacturer Narrative
One opened probe was received, without a tip protector, in a tray.The sample was visually inspected and found to be nonconforming with orange/brownish foreign material on the port face.The sample was then functionally tested for actuation, aspiration and cut.The sample was found to be conforming for all functional tests, no noise was observed.A review of the device history record traceable to the lot number obtained from the device¿s rfid (radio frequency identification) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be functionally conforming, therefore cutter made strange noise and actuation failure as described in the complaint were not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the returned probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CONSTELLATION SURGICAL PROCEDURE PACK
Type of Device
GENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8007579780
MDR Report Key16066682
MDR Text Key308479130
Report Number1644019-2022-01091
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/23/2023
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 Date03/31/2024
Device Catalogue Number8065752450
Device Lot Number14JCJE
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2022
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received02/22/2023
Supplement Dates FDA Received03/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CONSTELLATION VISION SYSTEM
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